MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WOVEN; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	87088
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to the manufacturer for analysis.A bend was observed at approximately 3.5cm from the distal end of the catheter.There was also a presence of foreign matter at the distal electrode.The catheter was tested for electrical properties and the catheter mated with no resistance.All circuits met specification for continuity, circuit resistance and intercircuit resistance.The reported failure was not confirmed through analysis.The device passed all relevant testing/ inspection.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.
Event or Problem Description
Reportable based on device analysis completed on 12 jun 2020.It was reported that the catheter had noisy electrograms.During an ablation procedure for atrial fibrillation with a woven diagnostic electrode catheter, about 2 hours into the procedure, noise appeared on electrodes 1-2 and 3-4 during connection.The catheter cable was replaced, but the issue was not resolved.The procedure was then completed using another manufacturer's device.Device analysis found foreign material at the distal electrode.

• Brand Name: WOVEN
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10188684
• Report Number: 2134265-2020-08459
• Device Sequence Number: 886837
• Product Code: DRF
• UDI-Device Identifier: 08714729900917
• UDI-Public: 08714729900917
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 06/24/2020

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: 12/28/2022
• Device Model Number: 87088
• Device Catalogue Number: 87088
• Device Lot Number: GFBZ2135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/12/2020
• Initial Report FDA Received Date: 06/24/2020
• 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
• Patient Weight: 47