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

Model Number	H74912161011
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The interventional wire in the patient's coronary artery came apart at the radiopaque to non-radiopaque section and doctor tried to use a second wire to lasso the wire, but unsuccessful.Doctor reached out to another interventional cardiologist (dr.(b)(6)), and dr.(b)(6) felt as if no ill effects would come from just leaving the wire tip in the vessel.Upon case completion, dr.(b)(6) spoke with the patient regarding results and the wire tip left in him.

• 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: 15949616
• Report Number: 15949616
• Device Sequence Number: 17735267
• Product Code: DQX
• UDI-Device Identifier: 08714729252528
• UDI-Public: (01)08714729252528(17)240328
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 12/06/2022
• Report Date (Section F): 12/06/2022

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 Model Number: H74912161011
• Device Catalogue Number: H74912161011
• Device Lot Number: 29130758
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/09/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/09/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 67 KG
• Patient Race: White
• Date Report Sent to FDA: 12/06/2022