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

Model Number	2080
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event was approximated from aware date as event date was not reported.
Event or Problem Description
It was reported that the tip detached.A choice pt wire was selected for a coronary percutaneous transluminal angioplasty (pta) procedure.During the pta procedure, the tip detached.There were no patient complications reported and the procedure was successfully completed.
Event or Problem Description
It was reported that the tip detached.A choice pt wire was selected for a coronary percutaneous transluminal angioplasty (pta) procedure.During the pta procedure, the tip detached.There were no patient complications reported and the procedure was successfully completed.It was further reported that a choice pt wire was selected for use in an artery below-the-knee (btk).The procedure was successfully completed with another of same device.There were no patient complications and the patient was stable post procedure.
Additional Manufacturer Narrative
B3 date of event was approximated from aware date as event date was not reported.

• Brand Name: CHOICE PT
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11020952
• Report Number: 2134265-2020-17993
• Device Sequence Number: 17283887
• Product Code: DQX
• UDI-Device Identifier: 08714729177012
• UDI-Public: 08714729177012
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2021

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: 09/26/2022
• Device Model Number: 2080
• Device Catalogue Number: 2080
• Device Lot Number: 0026084339
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/08/2020
• Supplement Date Received by Manufacturer: 12/17/2020
• Initial Report FDA Received Date: 12/16/2020
• Supplement Report FDA Received Date: 01/04/2021
• Patient Sequence Number: 1