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	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/15/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device evaluated by mfr: the device has a kink at approximately 13mm from the distal tip while in the neutral position.The kink is between r1 and r2.There is a significant amount of blood on r1 and the ring seal has been compromised.Pieces of the seal are missing on the underside of the kink.X-rays confirmed that both the center support and the steering wires are inside the sheath.The steering knob and the tension control knob functioned properly on both lock and unlock positions.The catheter was placed on the curve template and the device failed the left curve test.The distal end was dissected.The kevlar wrap is displaced and the center support is bent.One of the steering wires is detached from the center support; there is evidence of solder on both the center support and the detached steering wire.There is dried body fluid present on the wires, the kevlar wrap, and the underside of the r1.This is most likely a result of the r1 seal being compromised.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 analysis completed november 16, 2016.It was reported that the curve would not curve.The procedure was indicated for atrial flutter ablation.The intended location was the right atrium.An intellatip mifi¿ xp temperature ablation catheter was used.Following use, the curve would not curve.It was suspected that the steering wire broke.The procedure was completed with another of the same device.No patient complications were reported and the patient's status is fine.Returned device analysis revealed the ring seal was compromised.

• 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: 6155293
• Report Number: 2134265-2016-11081
• Device Sequence Number: 673634
• Product Code: OAD
• UDI-Device Identifier: 08714729848028
• UDI-Public: (01)08714729848028(17)20190517(10)0019265408
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 11/16/2016

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: 09/28/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2016
• Initial Report FDA Received Date: 12/08/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1