تسجيل الدخول
تسجيل جديد
الجمعة - محرم 2, 1447
عن تيقظ
بحث عن منتج
تقديم بلاغ
أسئلة شائعة
تواصل معنا
EN
SA-16-10-24-630
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
POLARX BALLOON CATHETER (Multiple models)
الأجهزة المتأثرة
(GTIN Number) (Material Number (UPN)) (Product Description) CRBS POLARX BALLOON CATHETER ST 28MM M004CRBS2000 08714729992561 CRBS POLARX BALLOON CATHETER LT 28MM M004CRBS2100 08714729992660 CRBS POLARX FIT BALLOON CATHETER ST M004CRBS2010 08714729992578 CRBS POLARX FIT BALLOON CATHETER ST M004CRBS2060 08714729992622 CRBS POLARX FIT BALLOON CATHETER LT M004CRBS2110 00191506016456 CRBS POLARX FIT BALLOON CATHETER LT M004CRBS2160 00191506016463
الممثل المعتمد
Boston Scientific Gulf for trading LLC
سبب المشكلة
AE fistula is a known and inherent risk for patients undergoing catheter ablation for atrial fibrillation. Although uncommon, esophageal injury is a potentially life-threatening complication due to proximity of the esophagus to the posterior left atrium.
الإجراء التصحيحي
1- Review the IFU Updates related to AE fistula, as detailed in Appendix 1. 2- Review Table 1 for a summary of cryoablation application parameters from the FROzEN AF clinical trial, which demonstrated safety and effectiveness of the POLARx Cryoablation System. 3- To provide awareness of this information, share this communication with clinicians in your hospital that use the Boston Scientific POLARx Cryoablation System, including the POLARx Catheter, the POLARx FIT Catheter and the SMARTFREEZE Console. Also share this communication with any other organization to which these devices may have been transferred. 4- Maintain a copy of this notice in your facility’s records.
المرفقات
عودة للقائمة
