MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PT; WIRE, GUIDE, CATHETER

Model Number	2779
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/02/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that guide wire coating issue occurred.A 185cm str pt guidewire was selected for use.However, during procedure, the coating was peeled off, and the 2.00mm x 8mm emerge balloon catheter lumen was clogged up in that coating.The procedure was completed with another of same device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned.Visual inspection found the distal tip of the guidewire was bent.Microscopic inspection found the polymer jacket coating of the guidewire had a detached section; this damage was located approximately at 69.5 inches from the proximal end.The polymer jacket that remained attached to the distal tip was found wrinkled.
Event or Problem Description
It was reported that guide wire coating issue occurred.A 185cm str pt guidewire was selected for use.However, during procedure, the coating was peeled off, and the 2.00mm x 8mm emerge balloon catheter lumen was clogged up in that coating.The procedure was completed with another of same device.No patient complications were reported.

• Brand Name: PT
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10504657
• Report Number: 2134265-2020-12415
• Device Sequence Number: 3222096
• Product Code: DQX
• UDI-Device Identifier: 08714729471189
• UDI-Public: 08714729471189
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K030617
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2020

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: 01/13/2022
• Device Model Number: 2779
• Device Catalogue Number: 2779
• Device Lot Number: 0025041692
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2020
• Initial Date Received by Manufacturer: 09/03/2020
• Supplement Date Received by Manufacturer: 09/23/2020
• Initial Report FDA Received Date: 09/08/2020
• Supplement Report FDA Received Date: 09/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1