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	Kinked (1339)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the device was received for analysis after decontamination; the upn and lot number match those provided by the customer.Visual inspection revealed a kink located approximately 14 cm from the distal tip between ring 1 and ring 2.The seal of ring one is compromised.The steering knob and the tension control knob functioned properly on both the lock and unlock positions.No abnormal resistance was felt when actuating the steering mechanism.Tip motion was evaluated against the specified curve template.The device failed the right curve test and the tip did not curve to the left.X-ray revealed a bent center support and evidence of guide coil collapse in the handle.The distal section was dissected; there was no visible body fluid inside the catheter.The kevlar wrap is displaced and the center support is bent.One of the steering wires is detached and there is evidence of solder on the center support.The detached steering wire had retracted under the kevlar wrap.The other steering wire is attached; however, the solder connection to the center support is cracked.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 analysis completed november 28th, 2017.It was reported that during an ablation procedure to treat atrial flutter, while heating the isthmus after inserting into the sheath, it was observed that the tip of the intellatip mifi¿ xp ablation catheter was kinked.The catheter was replaced to complete the procedure.There was no patient injury.However, returned device analysis revealed the seal on ring 1 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: 7112515
• Report Number: 2134265-2017-12218
• Device Sequence Number: 1234791
• Product Code: OAD
• UDI-Device Identifier: 08714729848011
• UDI-Public: 08714729848011
• Combination Product (Y/N): N
• PMA/510(K) Number: P020025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/28/2017

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: 12/01/2019
• Device Model Number: M004PM45000
• Device Catalogue Number: PM4500
• Device Lot Number: 20027551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2017
• Initial Report FDA Received Date: 12/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1