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

Model Number M004PM4790N40

Device Problems Signal Artifact/Noise (1036); Break (1069); Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/08/2014

Event Type  malfunction  

Event Description

Reportable based on analysis completed on (b)(4) 2014.It was reported that during an ablation treatment procedure distal wire inside the catheter broke and the distal tip was bent.The target lesion was located in the inferior vena cava (ivc) and the tricuspid valve (tv).This intellatip mifi xp ablation catheter was selected; however during the procedure, the distal wire of the catheter broke off and the distal tip was bent after several uses.They continued the procedure but distal noise appeared and distal portion potential became unavailable.The procedure was completed with another of the same device.No patient complications were reported and the patient's status is good.However, returned device analysis revealed that adhesive broke on a ring electrode number 2.

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).Device evaluated by manufacturer: examination of the returned complaint device revealed a kink at the distal section while in the neutral position and the adhesive broke on ring #2.In addition, the sample has evidence of fluids under the adhesives.An rf ablation test and electrical test were performed and the device met specification.A dimensional inspection revealed that the right and left curves were not placed in the template shaded areas, since the device has a kink at the distal section at 16mm from the tip.The device was dissected finding the center support broken at 16mm 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).

• 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 (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: 4456342
• MDR Text Key: 5421780
• Report Number: 2134265-2015-00163
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/17/2017
• Device Model Number: M004PM4790N40
• Device Catalogue Number: PM4790N4
• Device Lot Number: 16818653
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2014
• 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
• Treatment: GENERATOR: BSJ MAESTRO3000