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

Model Number	2777
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/02/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a coating issue was observed during preparation.Three 185cm pt guidewires were selected for use in a percutaneous coronary intervention in the left anterior descending (lad) artery.The first guidewire was removed from the packaging and the wire was noted to be damaged.The tip of the wire had no coating.The second and third guidewires were removed from the packaging and the tip broke during tip forming.The procedure was completed with another of the same device and there were no patient complications.
Event or Problem Description
It was reported that a coating issue was observed during preparation.Three 185cm pt guidewires were selected for use in a percutaneous coronary intervention in the left anterior descending (lad) artery.The first guidewire was removed from the packaging and the wire was noted to be damaged.The tip of the wire had no coating.The second and third guidewires were removed from the packaging and the tip broke during tip forming.The procedure was completed with another of the same device and there were no patient complications.It was further reported that the coating on the first guidewire was flaking.The third guidewire had flaking coating not a tip break as originally reported.These issues occurred outside the patient.
Additional Manufacturer Narrative
Describe event or problem: additional information.

• 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: 8731634
• Report Number: 2134265-2019-07325
• Device Sequence Number: 11263483
• Product Code: DQX
• UDI-Device Identifier: 08714729471110
• UDI-Public: 08714729471110
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2019

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: 04/03/2021
• Device Model Number: 2777
• Device Catalogue Number: 2777
• Device Lot Number: 0023594396
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/03/2019
• Supplement Date Received by Manufacturer: 06/25/2019
• Initial Report FDA Received Date: 06/25/2019
• Supplement Report FDA Received Date: 07/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1