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

Model Number	87092
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/27/2020
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 diagnostic electrode catheter was selected for a atrial fibrillation ablation procedure.When the packaging for the catheter was opened it was noted that distal tip was discolored and contaminated.Another woven catheter of the same lot selected for used however this catheter had the same issue.The procedure was completed without patient complications being reported by switching to a different product.
Event or Problem Description
It was reported that a woven diagnostic electrode catheter was selected for a atrial fibrillation ablation procedure.When the packaging for the catheter was opened it was noted that distal tip was discolored and contaminated.Another woven catheter of the same lot selected for used however this catheter had the same issue.The procedure was completed without patient complications being reported by switching to a different product.
Additional Manufacturer Narrative
The returned device was reported for the distal tip was discolored and contaminated.Visual inspection of the device revealed that there was foreign material on electrode #2.The strain relief was broken loose from the connecter and bends was observed at the distal end of the catheter.All electrical circuits met specification for continuity but intercircuit resistance failed to meet the specification requirement.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.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: 10420755
• Report Number: 2134265-2020-11279
• Device Sequence Number: 4060018
• 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): 09/28/2020

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: 08/25/2020
• Initial Date Received by Manufacturer: 07/27/2020
• Supplement Date Received by Manufacturer: 09/22/2020
• Initial Report FDA Received Date: 08/18/2020
• Supplement Report FDA Received Date: 09/28/2020
• Patient Sequence Number: 1
• Patient Age: 59 YR