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

Model Number	2080
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/04/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that tip detachment occurred, and procedure was cancelled.The target lesion was located in a superficial femoral artery.A 300cm (5pk) choice pt guidewire was inserted to the target lesion.However, during procedure, the guidewire became lodged behind the stent that was previously placed.When the guidewire was removed, the distal part approximately 10 cm broke off and remained in the vessel.The physician tried to snare the detached component but was unsuccessful.The tip was left inside the patient's body and the physician decided to stop.The procedure was not completed.No patient complications were reported.
Additional Manufacturer Narrative
E1 initial reporter title: updated from ms.(b)(6).E1 initial reporter first name: upddated from (b)(6).E1 initial reporter last name: updated from (b)(6).E1 initial reporter phone: updated from (b)(6).E3 occupation: updated from nurse to physician.
Event or Problem Description
It was reported that tip detachment occurred, and procedure was cancelled.The target lesion was located in a superficial femoral artery.A 300cm (5pk) choice pt guidewire was inserted to the target lesion.However, during procedure, the guidewire became lodged behind the stent that was previously placed.When the guidewire was removed, the distal part approximately 10 cm broke off and remained in the vessel.The physician tried to snare the detached component but was unsuccessful.The tip was left inside the patient's body and the physician decided to stop.The procedure was not completed.No patient complications were reported.

• Brand Name: CHOICE PT
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15601130
• Report Number: 2124215-2022-40562
• Device Sequence Number: 16726441
• Product Code: DQX
• UDI-Device Identifier: 08714729150633
• UDI-Public: 08714729150633
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 12/27/2022

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: 09/21/2023
• Device Model Number: 2080
• Device Catalogue Number: 2080
• Device Lot Number: 0028062191
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/05/2022
• Supplement Date Received by Manufacturer: 12/13/2022
• Initial Report FDA Received Date: 10/13/2022
• Supplement Report FDA Received Date: 12/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2021
• 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: Male