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

Model Number	87092
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/01/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the catheter tip showed signs of burning on the distal electrode.Prior to an ablation procedure to treat atrial fibrillation, while unpacking the device, it was noticed that the distal tip electrode showed "signs of burning" and was greyer in appeared compared to the other electrodes.No patient complications occurred as the issue occurred outside of the patient.The procedure was completed with a different device.
Additional Manufacturer Narrative
The device was returned for analysis.Visual inspection showed the discoloration on the electrodes 1-4.The returned sample was tested for electrical resistance.All circuits meet specification for continuity and intercircuit resistance.All electrodes were smooth with no sharp edges.The photos attachments were reviewed, there did appear to be discoloration on electrodes 1-4.The sample was reviewed under 10x magnification, can clearly see "circumferential" buff marks indicating that the electrodes were cleaned.There was no evidence of excess "co" on the electrodes.The sample was wiped with isopropyl alcohol and the discoloration remained on the electrodes 1-4.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.
Event or Problem Description
It was reported that the catheter tip showed signs of burning on the distal electrode.Prior to an ablation procedure to treat atrial fibrillation, while unpacking the device, it was noticed that the distal tip electrode showed "signs of burning" and was greyer in appeared compared to the other electrodes.No patient complications occurred as the issue occurred outside of the patient.The procedure was completed with a different device.

• 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: 9253955
• Report Number: 2134265-2019-13160
• Device Sequence Number: 1864909
• 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): 01/15/2020

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: 03/28/2024
• Device Model Number: 87092
• Device Catalogue Number: 87092
• Device Lot Number: GFDQ0334
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2019
• Initial Date Received by Manufacturer: 10/01/2019
• Supplement Date Received by Manufacturer: 01/10/2020
• Initial Report FDA Received Date: 10/29/2019
• Supplement Report FDA Received Date: 01/15/2020
• Patient Sequence Number: 1
• Patient Age: 48 YR