MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) BLAZER PRIME® HTD; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number M004P5031THN40

Device Problem Kinked (1339)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by manufacturer: the device was returned for analysis.The unit returned has the distal tip kinked, as part of overall visual revision.The device has a kink at 13mm from the tip while in the neutral position.In addition, the ring #2 has broken adhesive and fluids under it.The distal section was dissected finding the center support kinked at 13mm from the tip.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).

Event Description

Reportable based on device analysis completed on 03may2016.It was reported that a kink was noted on the distal electrode.The lesion was located in the proximal left anterior descending artery (lad).A 110-2.5-7-4 blazer prime® htd was selected for use.During unpacking, outside the patient, it was noted that the distal electrode became kinked.The procedure was completed with another of the same device and the patient's status was stable.However, device analysis revealed that the ring #2 has broken adhesive.

• Brand Name: BLAZER PRIME® HTD
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; 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: 5688491
• MDR Text Key: 46192586
• Report Number: 2134265-2016-04443
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: P920047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/26/2018
• Device Model Number: M004P5031THN40
• Device Catalogue Number: P5031THN4
• Device Lot Number: 0018339977
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2016
• Date Manufacturer Received: 03/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2015
• 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