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

Model Number 87092

Device Problems Contamination (1120); Material Perforation (2205)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/27/2020

Event Type  malfunction  

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 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 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.

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
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10087918
• MDR Text Key: 192027397
• Report Number: 2134265-2020-06987
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 08714729902355
• UDI-Public: 08714729902355
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• 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 Manufacturer Received: 04/27/2020
• Initial Date FDA Received: 05/26/2020
• Supplement Dates Manufacturer Received: 08/31/2020
• Supplement Dates FDA Received: 09/14/2020
• Patient Sequence Number: 1
• Patient Age: 50 YR