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	M004PM4500K20
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Visual inspection showed there was a kink between rings 1 & 2.Dried body fluid was found on the handle and distal end.X-rays showed a steering wire had separated from the center support.The other steering wire was firmly attached to the center support, but they were both severely bent between rings 1 & 2.Continuity checks revealed no electrical opens or shorts, as checked manually using a multi-meter and breakout box.All electrode/thermistor/sensor resistances measured in spec and were typical.The ablation was verified by using the maestro generator 4000.Error code m11: rf power reduced by 50% - max temp reached¿, occurred after 90 sec.Error code m11: rf power reduced by 50% - max temp reached, occurred after 70 sec.The steering knob and the tension control knob functioned properly on both lock and unlock positions.No abnormal resistance was felt when actuating the steering mechanism.The distal section was dissected.Body fluid was found under each of the three rings and throughout the dissected area.Ingress of the body fluid could not be determined.All ring seals appeared intact even when the distal tip was manipulated.A steering wire had detached from the center support.There was evidence of solder between the center support and the detached steering wire.The other steering wire was still attached to the center support, but they were both severely bent in the area between rings 1 & 2.The kevlar wrap was displaced back to the proximal side of the center support bend.A thermistor wire has been cut exposing bare copper.The cut aligns with the sharp edge of the bent center support.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).
Event or Problem Description
Reportable based on device analysis completed on 08dec2017.It was reported that a temperature sensor failed.During an ablation procedure with an intellatip mifi xp ablation catheter, a temperature sensor failed.The catheter was replaced and the procedure was completed with a different device.No patient complications occurred.Device analysis revealed body fluid ingress.

• Brand Name: INTELLATIP MIFI¿ XP TEMPERATURE ABLATION CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• MDR Report Key: 7138060
• Report Number: 2134265-2017-12904
• Device Sequence Number: 11130860
• Product Code: OAD
• UDI-Device Identifier: 08714729848028
• UDI-Public: 08714729848028
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: P020025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/08/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/23/2020
• Device Model Number: M004PM4500K20
• Device Catalogue Number: PM4500K2
• Device Lot Number: 0020196357
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2017
• Initial Report FDA Received Date: 12/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1