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 M004EPM4500K20

Device Problems Electrical /Electronic Property Problem (1198); Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/29/2015

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: unit returned in a generic plastic bag.The unit returned has distal end kinked, as part of overall visual revision.The returned device matches with upn and lot provided by the customer.The device has a kink at 13mm from the tip while in the neutral position (between ring 1 and 2).In addition the ring#1 and #2 has broken adhesive and fluids under them.The ablation was verified by using the maestro generator 4000 and the device was found within specifications.Electrical test was performed and the device was found out of specifications.The me3 has an electrical open line.The right curve is placed in the template shaded area, but the left curve is out of the template shaded area.The device failed the dimensional test.Based on the x-ray images the ol was identified at 8.7cm from the tip.The affected area was dissected finding the me3 wire broken in 3 sections and it also was bent.The handle was opened, and no issues were detected in that section.The distal section was dissected finding the center support kink at 13 mm from the tip and has over tension on it, it causes that the center support to leave the regular position.When the steering wires were released the tension on the center support disappear.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause was unable to be determined.(b)(4).

Event Description

Reportable based upon analysis completed on 24aug2015.It was reported that the shaft was kinked and an electrode failed.The lesion being treated was located in the right atrium.While using an intellatip mifi¿ xp temperature ablation catheter it was noted that electrode 1 failed.Upon removal, the device shaft was kinked at the distal end.The procedure was completed with another of the same device and no patient complications were reported.Device analysis found lifted electrodes.Device analysis found broken adhesive.

• 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: 5095702
• MDR Text Key: 26474665
• Report Number: 2134265-2015-06245
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: P020025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Report Date: 08/24/2015

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: 02/18/2017
• Device Model Number: M004EPM4500K20
• Device Catalogue Number: EPM4500K2
• Device Lot Number: 16743764
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2014
• 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