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 M004PM4790N40

Device Problems Bent (1059); Device Sensing Problem (2917)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/24/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Age at time of event: 18 years or older.(b)(4).Device evaluated by manufacturer - the device has a kink at 13mm from the tip.In addition has char in the base of the tip and the ring #1 and broken adhesive on it.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 device has a intermittent short between tip and r1.The handle was opened finding no issues to the connector.The stiffening rod was removed identified a possible affected area, however, no issues were identified.The stiffening rod has not damages on it.The device was dissected after the torque hole finding the following: the r1 wire is peeled close to the ring soldering.This area match with the kink in the center support and a burning mark in the tip wire.This caused the short between tip and r1.Evidence of fluids was found inside the shaft.Regarding the kink in the distal section the device was dissected finding the center support kinked at 14mm 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 analysis completed on 04oct2015.It was reported that tip damage and loss of signal occurred.Ablation was performed with an intellatip mifi xp temperature ablation catheter, however the 1-2 electric potential stopped appearing.Upon removal the tip of the catheter was noted to be deformed.The device was exchanged to another intellatip mifi xp temperature ablation catheter to complete the procedure.No additional patient complications were reported and the patient status is good.However; returned device analysis revealed char on the catheter tip and peeling between the electrodes.

• 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: 5188381
• MDR Text Key: 29859381
• Report Number: 2134265-2015-07274
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/04/2015

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: 12/07/2017
• Device Model Number: M004PM4790N40
• Device Catalogue Number: PM4790N4
• Device Lot Number: 17511087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/04/2015
• Initial Date FDA Received: 10/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/18/2014
• 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