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	05/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The catheter was received for analysis after decontamination.The returned device matches the upn and lot number provided by the customer.Visual inspection found a kink located approximately 1.5cm from the distal tip between ring1 and ring2.Both ring 1 and ring 2 seals were compromised.There was a section of the proximal seal on ring 1 missing.Functional inspection found 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.Tip motion was evaluated against the specified curve template/fixture.The right curve test passed, but had an irregular shape due to a kink.The left curve failed to reach the specified template area; the tip does not curve to the left.X-ray analysis showed a bent center support.There was no evidence of guide coil collapse.The distal section was dissected.There was body fluid under ring 1, and in the interior of the sheath.The kevlar wrap was displaced and the center support was 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 detached steering wire had retracted under the kevlar wrap.The manufacturing batch record review confirmed that the device met all material, assembly and performance specification.Complaint confirmed.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 18sept2017.It was reported the steering mechanism of the catheter broke.The intellatip mifi¿ xp temperature ablation catheter was selected for treatment of right atrial flutter.It was noted that the steering mechanism broke.No patient complications were reported.However device analysis found electrode ring 1 and ring 2 seals were compromised.Body fluid was found under ring 1, and in the interior of the sheath.

• 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: 6907111
• Report Number: 2134265-2017-09782
• Device Sequence Number: 745224
• Product Code: OAD
• UDI-Device Identifier: 08714729848028
• UDI-Public: 08714729848028
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Physician
• Device Expiration Date: 12/19/2019
• Device Model Number: M004PM4500K20
• Device Catalogue Number: PM4500K2
• Device Lot Number: 20094811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2017
• Initial Report FDA Received Date: 10/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR