MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) BLAZER PRIME? XP; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number M004EPTP4500THN40

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/15/2014

Event Type  malfunction  

Event Description

Reportable upon analysis completed on (b)(4) 2014.It was reported that the shaft was kinked.The lesion being treated was located in the isthmus.A blazer prime¿ xp ablation catheter was advanced to treat the lesion, however it was noted the tip was kinked.The device was successfully removed.The procedure was completed with another of the same device.No patient complications were reported and the patient is fine.Device analysis found that an electrode was lifting.

Manufacturer Narrative

Device evaluated by mfr: unit returned with its original pouch batch 16281471 - upn (b)(4).The device has a kink at the distal section while in the neutral position at 1.7cm from the tip.In addition the device has a broken adhesive on ring#2.The ring damage location match with kink location.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

• Brand Name: BLAZER PRIME? XP
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4395769
• MDR Text Key: 16306182
• Report Number: 2134265-2014-08039
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• PMA/PMN Number: P020025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/07/2016
• Device Model Number: M004EPTP4500THN40
• Device Catalogue Number: EPTP4500THN4
• Device Lot Number: 16281471
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/10/2014
• Initial Date FDA Received: 01/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 60 YR