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

Model Number	2045
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that guidewire tip detachment occurred.The 95% stenosed target lesion was located in the severely tortuous and severely calcified proximal right coronary artery.A 182 cm choice pt guidewire was advanced for treatment.However, upon putting the guidewire down the vessel, it became stuck.The physician attempted to remove the guidewire but upon pulling the guidewire out of the guide, it broke, and the uncoiled tip of the guidewire was left in the patient.A snare was used in an unsuccessful attempt to remove the guidewire fragment.The patient was sent to surgery to retrieve the guidewire tip and have coronary artery bypass graft (cabg) surgery performed.No patient complications were 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: 17376232
• Report Number: 2124215-2023-37341
• Device Sequence Number: 7214247
• Product Code: DQX
• UDI-Device Identifier: 08714729252535
• UDI-Public: 08714729252535
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 07/23/2023

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: 01/23/2025
• Device Model Number: 2045
• Device Catalogue Number: 2045
• Device Lot Number: 0030912464
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/30/2023
• Initial Report FDA Received Date: 07/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2023
• 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