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

Model Number	2040
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that tip detachment occurred.The patient presented for a pacemaker implant.A 182 cm j choice guidewire was selected for use.However, during the procedure, the tip of the wire sheared off inside the patient.The physician attempted to retrieve the broken piece but was unsuccessful.The procedure was completed, but the tip of the wire remains in the patient.There were no patient complications reported.
Additional Manufacturer Narrative
The device was returned for analysis.Visual and microscopic inspection revealed the distal section was bent and the distal tip was detached.The tip was not returned for analysis.The total length of the guidewire was found to be within product specification even though the distal tip was detached.
Event or Problem Description
It was reported that tip detachment occurred.The patient presented for a pacemaker implant.A 182 cm j choice guidewire was selected for use.However, during the procedure, the tip of the wire sheared off inside the patient.The physician attempted to retrieve the broken piece but was unsuccessful.The procedure was completed, but the tip of the wire remains in the patient.There were no patient complications reported.

• Brand Name: CHOICE PT
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19855987
• Report Number: 2124215-2024-46549
• Device Sequence Number: 6821142
• Product Code: DQX
• UDI-Device Identifier: 08714729177005
• UDI-Public: 08714729177005
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/02/2025
• Device Model Number: 2040
• Device Catalogue Number: 2040
• Device Lot Number: 0032553610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2024
• Supplement Date Received by Manufacturer: 11/14/2024
• Initial Report FDA Received Date: 07/29/2024
• Supplement Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown