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	06/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that guidewire coating peeled off.A 185cm pt2 guidewire was selected for use.However, during advancing, the physician felt that the wire was different than usual.After procedure, it was noted that the coating or the wire was slightly peeled off.The procedure was completed with another of the same device.No patient complications nor injuries reported.
Event or Problem Description
It was reported that guidewire coating peeled off.A 185cm pt2 guidewire was selected for use.However, during advancing, the physician felt that the wire was different than usual.After procedure, it was noted that the coating or the wire was slightly peeled off.The procedure was completed with another of the same device.No patient complications nor injuries reported.
Additional Manufacturer Narrative
E1 - initial reporter city: (b)(6).Device evaluated by mfr: the device was returned for analysis.The guidewire was returned inside of a protective hoop.The device was easily removed from the protective hoop.The returned guidewire had the distal tip bent.The coating of the guidewire was carefully inspected and no damages nor deformations were found on its surface.No more visual damages were encountered.

• 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: 10200143
• Report Number: 2134265-2020-08581
• Device Sequence Number: 14011906
• 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): 08/11/2020

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: 01/02/2022
• Device Model Number: 2779
• Device Catalogue Number: 2779
• Device Lot Number: 0024986130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2020
• Initial Date Received by Manufacturer: 06/23/2020
• Supplement Date Received by Manufacturer: 08/06/2020
• Initial Report FDA Received Date: 06/26/2020
• Supplement Report FDA Received Date: 08/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1