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

Model Number	2779
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: used the first date of the month of the aware date as no event date was provided.
Event or Problem Description
It was reported that distal tip detachment occurred.A 185cm j-tip pt guidewire was selected for use.However, upon opening for use, it was observed that the tip had a crack or breakage.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
(b3) date of event: used the first date of the month of the aware date as no event date was provided.
Event or Problem Description
It was reported that distal tip detachment occurred.A 185cm j-tip pt guidewire was selected for use.However, upon opening for use, it was observed that the tip had a crack or breakage.The procedure was completed with another of the same device.No patient complications were reported.It was further reported that upon opening the guidewire for its use during preparation, it was observed that its tip was damaged, making its use impossible.

• 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: 9865259
• Report Number: 2134265-2020-03672
• Device Sequence Number: 16960953
• Product Code: DQX
• UDI-Device Identifier: 08714729471202
• UDI-Public: 08714729471202
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K030617
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2020

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: 06/24/2021
• Device Model Number: 2779
• Device Catalogue Number: 2779
• Device Lot Number: 0024008087
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/06/2020
• Supplement Date Received by Manufacturer: 04/22/2020
• Initial Report FDA Received Date: 03/23/2020
• Supplement Report FDA Received Date: 05/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1