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

Model Number	2000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/01/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that guide wire tip fracture occurred.During unpacking of a 182 cm choice guide wire, a fracture of the tip was noted.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.The guidewire returned inside of a hoop.The hoop did not show damages.The guidewire had the distal tip bent and kinked; the kinked section was located approximately at 0.3 cm from the proximal end.The body of the guidewire was kinked approximately at 171.7 cm and 172.7 cm from the proximal end.No more damages were found.
Event or Problem Description
It was reported that guide wire tip fracture occurred.During unpacking of a 182cm choice guide wire, a fracture of the tip was noted.The procedure was completed with another of the same device.No patient complications were reported.

• Brand Name: CHOICE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8914640
• Report Number: 2134265-2019-09964
• Device Sequence Number: 14141516
• Product Code: DQX
• UDI-Device Identifier: 08714729252351
• UDI-Public: 08714729252351
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K143587
• 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): 11/20/2019

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: 03/28/2021
• Device Model Number: 2000
• Device Catalogue Number: 2000
• Device Lot Number: 0023563801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2019
• Initial Date Received by Manufacturer: 08/13/2019
• Supplement Date Received by Manufacturer: 11/06/2019
• Initial Report FDA Received Date: 08/21/2019
• Supplement Report FDA Received Date: 11/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1