MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTELLATIP MIFI OPEN-IRRIGATED; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number	86493
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for analysis.Visual inspection revealed dried body fluid on the handle, main shaft, and distal end.Dried saline were also found on the distal end and inside several irrigation ports.Electrical tests found no shorts or opens and were in spec and typical.No abnormal resistance were felt when actuating the steering mechanism.Noise testing in ablation condition exceeded current device specifications.X-ray imaging found dried fluid debris inside the tip.Evidence of fluid ingress was found inside the distal tip, which can cause electrical noise.
Event or Problem Description
Reportable based on device analysis completed on 07-aug-2019.It was reported that a noisy electrogram occurred.During an ablation procedure for paroxysmal supraventricular tachycardia (psvt) with an intellatip mifi open-irrigated (oi) catheter, while in the right atrium noise occurred in the tip electrode 1-2 after the catheter was inserted into the body.The cable was replaced but the issue was not resolved.A new intellatip mifi oi catheter was used and noise in all electrodes were also noted.The peripheral equipment was turned off, and cables were arranged, and the arrangement of connection box was changed, but the issue was not resolved at all.The position of the return electrode was changed, and tried pacing from the catheter, but the issue was not resolved.The procedure was completed with a non-bsc catheter.No patient complications occurred.However, device analysis showed fluid ingress inside the distal tip.

• Brand Name: INTELLATIP MIFI OPEN-IRRIGATED
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 8947185
• Report Number: 2134265-2019-10438
• Device Sequence Number: 19357593
• Product Code: OAD
• UDI-Device Identifier: 08714729848684
• UDI-Public: 08714729848684
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P150005/S008
• 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): 08/29/2019

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: 02/10/2022
• Device Model Number: 86493
• Device Catalogue Number: 86493
• Device Lot Number: 0023329676
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2019
• Initial Report FDA Received Date: 08/29/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INTELLATIP MIFI OPEN-IRRIGATED