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	M004PM47900
Medical Device Problem Code	Insufficient Heating (1287)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: over 18.(b)(4).Device evaluated by mfr the returned device matches the upn and lot number provided by the customer.Visual inspection showed that there is a kink located approximately 1.5 cm from the distal tip between the ring #1 and ring #2.There is also a small amount of body fluids under r2 ring since broken adhesive was observed.Electrical test was performed and continuity checks revealed no electrical opens or shorts.Functional inspection was performed and 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.X-ray showed a bent center support.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is not confirmed - returned as there was no evidence of either the alleged issue(s) or any defect which could have contributed to the event.(b)(4).
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2018.It was reported that the device was unable to ablate.A intellatip mifi¿ xp temperature ablation catheter was selected for a atrial flutter(afl) ablation.However ablation was performed with 60w and 60 degrees settings, but while the w increased, the temperature did not increase more than about 40 degrees, and it did not change without reducing the potential of the mini electrode of mifi.Ablation was performed for about 15 times, the procedure was completed with another intellatip mifi.No complications were reported.However analysis reveled broken ring 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: 7285931
• Report Number: 2134265-2018-00831
• Device Sequence Number: 1824030
• Product Code: OAD
• UDI-Device Identifier: 08714729848042
• UDI-Public: 08714729848042
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/23/2018

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: 03/15/2020
• Device Model Number: M004PM47900
• Device Catalogue Number: PM4790
• Device Lot Number: 20413820
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2018
• Initial Report FDA Received Date: 02/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1