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	M004PM4790K20
Medical Device Problem Codes	Signal Artifact/Noise (1036); Bent (1059)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device evaluated by mfr: analysis of returned product revealed the unit passed electrical and rf ablation testing, consequently, not confirming the reported complaint of "noisy electrogram"; however, the device had a kink at the distal section-approximately the distal section while in the neutral position-ring 1 seals were compromised; there was dried body fluid on the edge of the electrode.Bent center support and a steering wire partially detached from the center support were observed under x-ray between r1 and r2 at the distal section.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
This event is reportable based on device analysis completed 4/6/18.It was reported that upon ablation in the right atrium, noise appeared on the 1-2 bipolar display.It was necessary to replace the catheter to complete the procedure.No patient complications occurred.It was also noted that the tip of the catheter was bent out of the box.Device analysis revealed a compromised seal on ring 1.

• 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: 7483456
• Report Number: 2134265-2018-03640
• Device Sequence Number: 109334
• Product Code: OAD
• UDI-Device Identifier: 08714729848059
• UDI-Public: 08714729848059
• 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): 04/06/2018

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: 08/15/2020
• Device Model Number: M004PM4790K20
• Device Catalogue Number: PM4790K2
• Device Lot Number: 21017230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2018
• Initial Report FDA Received Date: 05/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1