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	M004PM45000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device evaluated by manufacturer ¿the product returned has a kink located approximately 13cm from the distal tip between the ring 1 and ring 2.Ring 1 seal is compromised and there is body fluid under the seal.Tip motion was evaluated against the specified curve template/fixture.The left curve failed to reach the specified template area; the tip does not bend to the left.The right curve test passed, but had an irregular shape due to a kink.The x-ray showed a bent center support.The distal section was dissected and a very small amount of body fluid under r1 ring.The kevlar wrap is displaced and the center support is bent.Dissection showed one steering wire was detached from the center support.There was sign of a typical solder connection between the center support and detached steering wire.The attached steering wire solder joint is cracked.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 or Problem Description
Reportable based on analysis completed on (b)(6) 2017.It was reported that the catheter steering mechanism broke.Right atrial fibrillation ablation was attempted using a intellatip mifi¿ xp temperature ablation catheter.During ablation the catheter steering mechanism broke, so it was replaced with a new device and the procedure was completed.No complications were reported and the patient is fine.However; returned device analysis revealed the seal of ring 1 is 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: 6917665
• Report Number: 2134265-2017-09763
• Device Sequence Number: 1026082
• Product Code: OAD
• UDI-Device Identifier: 08714729848011
• UDI-Public: 08714729848011
• 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): 09/18/2017

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: 12/16/2019
• Device Model Number: M004PM45000
• Device Catalogue Number: PM4500
• Device Lot Number: 20089289
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2017
• Initial Report FDA Received Date: 10/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1