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 Displays Incorrect Message (2591)
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
The device was returned for analysis.The returned device matches the upn and lot number provided by the customer.There was a kink between rings 1 & 2.Dried body fluid was found on the handle, distal tip, and under the ring 1 proximal seal.X-rays showed a steering wire has 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 found an electrical short between tip and th when the distal curve was straight and bent to the right.All other electrical measurements were in specification.During the rf ablation test, the maestro generator could not find the catheter when the distal tip was in the right curve position.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 throughout the dissected area.A steering wire was detached from the center support due to a broken solder joint.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 the wire and support were severely bent in the area between rings 1 & 2.The kevlar wrap was displaced back to the proximal side of the bend in the center support.A thermistor wire had been cut, exposing bare copper.The cut aligned 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 design specification as the device problem was traced back to the design specifications.(b)(4).
Event or Problem Description
Reportable based on device analysis completed on 18dec2017.It was reported that a temperature sensor failure error (d06) occurred.During an ablation procedure, in the right atrium, with an intellatip mifi xp ablation catheter, the temperature sensor failed and error code d06 displayed.The physician replaced the catheter with a 10mm mifi and the procedure was completed.No patient complications occurred.Device analysis revealed dried body fluid under the ring 1 proximal seal.

• 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: 7176148
• Report Number: 2134265-2017-13024
• Device Sequence Number: 96945
• 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): 12/18/2017

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: 12/18/2017
• Initial Report FDA Received Date: 01/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1