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 09/24/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by manufacturer - the device has a kink at 15mm from the tip while in the neutral position between ring 1 and 2.In addition the ring #1, #2 & #3 have broken adhesive and fluids under them.The steering knob and the tension control knob functioned properly on both lock and unlock positions.Dimensional inspection revealed that both curves are placed in the template shaded area.The ablation was verified by using the maestro generator 4000, and the maestro 4000 displayed a d06 error code.Electrical test was performed and the device was found out of specifications.The device has an electrical open line in the thermistor cable, high resistance on me1.X ray analysis revealed that the center support is kinked, but no evidence of the open line was noticed.The handle was opened finding no issues to the connector.The shaft was dissected finding the me1 wire damage at 60cm from the tip.This damage could cause the high resistance.The distal tip was dissected finding the thermistor wire twisted, broken and has a char on the broken area at 3.5 from the base of the tip.In addition the wire was twisted at 5cm from the base of 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 23nov2015.It was reported that the signal noise and a kink occurred.Mid way through an ablation procedure in the right ventricle with an intellatip mifi (tm) xp temperature ablation catheter a system error "ee" was observed on the non-bsc generator.Upon physical assessment of the mifi catheter it was noted that there was a kink in the distal portion near the tip.The physician indicated that this was very likely due to him forcing the catheter against the sheath.The device was exchanged with another intellatip mifi (tm) xp temperature ablation catheter to complete the procedure.No patient complications were reported and the patient status is stable.However; returned device 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: 5300168
• MDR Text Key: 33587227
• Report Number: 2134265-2015-08519
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/27/2017
• Device Model Number: M004EPM4500K20
• Device Catalogue Number: EPM4500K2
• Device Lot Number: 16837744
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2014
• 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