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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the catheter was returned for analysis.A visual examination of the catheter found the device had a kink at approximately 13mm from the distal tip while in the neutral position.The kink was between r1 and r2.There was what appears to be dried body fluid under the r2 seal.The steering knob and the tension control knob functioned properly on both lock and unlock positions.An electrical test was performed which revealed that when the device was in the cw position there was a resistive short between the thermistor and the tip.This measurement was expected to be an open.Also, it was noted that in the straight position, all resistance measurements were within specifications, however, in the cw position the thermistor measurement was low.The device was connected to the maestro generator 4000 and the device was found by the maestro in the straight position, but in the cw position the maestro could not find the catheter.X-rays were taken of the device in the cw position.No abnormalities with the wires were visible.The device was then dissected.The kevlar wrap was displaced and the center support was bent.One steering wire was detached.There was evidence of solder on both the center support and the detached steering wire.Dried body fluid was present.Visual examination revealed that the insulation of the thermistor wire was breached in the location that corresponds to the bend of the center support and the attached steering wire.The center support/steering wire was connected to the device tip.The location of the thermistor wire and its insulation breach suggests that when the center support bent, its edge scrapped the thermistor insulation making a connection between the center support and the thermistor.Because the center support is connected to the tip, a resistive short was present between the tip and thermistor when the device was in the cw position.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause of the reported difficulty is a design constraint of the product.(b)(4).
Event or Problem Description
Reportable based on device analysis completed on 05dec2016.It was reported that a "sensor failure" message "d08" occurred.During an ablation procedure with a intellatip mifi xp ablation catheter, they had a "sensor failure" message "d08" on the maestro.The physician replaced the catheter and they were able to finish the case.There were no adverse impacts to the patient.Device analysis revealed dried body fluid under the r2 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: 6198414
• Report Number: 2134265-2016-11832
• Device Sequence Number: 415315
• Product Code: OAD
• UDI-Device Identifier: 08714729848028
• UDI-Public: (01)08714729848028(17)20190517(10)0019265408
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 12/05/2016

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: 05/17/2019
• Device Model Number: M004PM4500K20
• Device Catalogue Number: PM4500K2
• Device Lot Number: 0019265408
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2016
• Initial Report FDA Received Date: 12/22/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1