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

Model Number	87092
Medical Device Problem Codes	Contamination (1120); Material Perforation (2205)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that a woven 7f diagnostic electrode catheter was selected for a ventricular tachycardia (vt) ablation procedure.It was noted that visually the catheter coating was peeling and there where contaminates on the catheter.The catheter was not used and the procedure was competed with another woven catheter with no patent complications being reported.
Event or Problem Description
It was reported that a woven 7f diagnostic electrode catheter was selected for a ventricular tachycardia ablation procedure.However it was noted that the catheter had a peeling feeling and contaminates on the catheter.The catheter was not used and the procedure was competed with another woven catheter with no patent complications being reported.
Additional Manufacturer Narrative
The device was returned with the aligation of a peeling feeling and contaminates on the catheter.The visual inspection of the device revealed that the electrodes were smooth and no sharp edges.The returned device showed no evidence of the reported allegation.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.

• 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: 10087918
• Report Number: 2134265-2020-06987
• Device Sequence Number: 2561225
• Product Code: DRF
• UDI-Device Identifier: 08714729902355
• UDI-Public: 08714729902355
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Followup
• Report Date (Section B): 09/14/2020

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: 12/28/2024
• Device Model Number: 87092
• Device Catalogue Number: 87092
• Device Lot Number: GFDY0416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2020
• Initial Date Received by Manufacturer: 04/27/2020
• Supplement Date Received by Manufacturer: 08/31/2020
• Initial Report FDA Received Date: 05/26/2020
• Supplement Report FDA Received Date: 09/14/2020
• Patient Sequence Number: 1
• Patient Age: 50 YR