MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) INTELLATIP MIFI? XP TEMPERATURE ABLATION CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number M004PM4500K20

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/10/2014

Event Type  malfunction  

Event Description

Reportable based on the product analysis completed on (b)(4) 2014.Physician had the intellatip mifi¿ xp temperature ablation catheter looped in the right atrium and was attempting to ablate the cavotricuspid isthmus region.It was then noticed that the distal tip of the catheter was bending awkwardly under fluoro.The catheter was removed from the patient and it was noted to have an odd bend between the distal tip and ring electrodes.The procedure was completed with a blazer ii xp 10mm.No reported patient complications and the patient status was fine.However, the returned product analysis revealed broken adhesive under the rings on the distal tip.

Manufacturer Narrative

Device evaluated by manufacturer: a visual examination identified a kink at the distal section while in the neutral position at 1.3cm from the tip.In addition the device has broken adhesive and fluid residues under the adhesive at ring#1 and ring#2.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: INTELLATIP MIFI? XP TEMPERATURE ABLATION CATHETER
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• 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: 4329531
• MDR Text Key: 5137384
• Report Number: 2134265-2014-08111
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/16/2017
• Device Model Number: M004PM4500K20
• Device Catalogue Number: PM4500K2
• Device Lot Number: 16648186
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/19/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2014
• 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