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

Model Number	2480
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that guidewire fracture occurred.A pt graphix guidewire was selected; however during the procedure the coronary wire fractured.
Event or Problem Description
It was reported that guidewire fracture occurred.A pt graphix guidewire was selected; however during the procedure the coronary wire fractured.It was further reported that this event is a duplicate of mdr report number 2134265-2021-11321.

• Brand Name: PT GRAPHIX
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12549008
• Report Number: 2134265-2021-12252
• Device Sequence Number: 1101291
• Product Code: DQX
• UDI-Device Identifier: 08714729141723
• UDI-Public: 08714729141723
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K143587
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2021

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: 10/09/2021
• Device Model Number: 2480
• Device Catalogue Number: 2480
• Device Lot Number: 0024578592
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/03/2021
• Supplement Date Received by Manufacturer: 09/29/2021
• Initial Report FDA Received Date: 09/29/2021
• Supplement Report FDA Received Date: 10/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1