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 M004EPM4500K20

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/29/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by manufacturer - the device has a kink at 13mm from the tip while in the neutral position between ring 1 and 2.In addition the rings #1 and #2 have broken adhesive and fluids under them.The steering knob and the tension control knob functioned properly on both lock and unlock positions.The right curve is placed in the template shaded area, however, the device did not curve to the left.The device failed the dimensional test.The handle was opened, and a gap was found in the terminal of the steering wire.The guide coil was inspected and no issues were found.The distal section was dissected and one of the steering wires was found detached from the center support.The steering wire and center support have evidence of soldering process.The center support was found 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 analysis completed on (b)(4) 2015.It was reported that the signal noise and a kink occurred.Approximately 40 minutes into an atrial flutter ablation procedure in the right atrium with an intellatip mifi xp temperature ablation catheter the physician noticed that one of the pull wires in the catheter had broken and deflection wasn't possible in one direction.The procedure was completed with another intellatip mifi xp temperature ablation catheter.No patient complications were reported and the patient status is stable.However, analysis revealed broken adhesive 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: 5307339
• MDR Text Key: 33790482
• Report Number: 2134265-2015-08686
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: GB
• 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: 11/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2017
• Device Model Number: M004EPM4500K20
• Device Catalogue Number: EPM4500K2
• Device Lot Number: 16923708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2014
• 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