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

Model Number	2040
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via medwatch (b)(4) that guidewire distal tip detachment and a device fragment remained in the patient.A 182cm choice pt guidewire was advanced for use.However, during the implantation of the pacemaker, the distal tip of the wire sheared off inside the patient.A snare was attempted but was unsuccessful leaving the tip of the wire inside the patient.No patient complications were reported and the patient was stable post-procedure.

• 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: 20311153
• Report Number: 2124215-2024-59642
• Device Sequence Number: 15674268
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/26/2024

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2024
• Initial Report FDA Received Date: 09/26/2024
• Date Device Manufactured: 10/03/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown