MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION V-18 CONTROL WIRE; WIRE, GUIDE, CATHETER

Model Number	40535
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/24/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that guidewire tip detachment occurred.Physician was performing a lower extremity pulmonary vein isolation (pvi).A 300cm, 12cm v-18 control wire was used to cross the lesion.However, during the procedure, the tip of the guidewire was fractured.The device was then removed but the tip was retained in the vessel.The detached tip could not be retrieved.No patient complications were reported after the tip detachment and the patient fully recovered.
Additional Manufacturer Narrative
Unit was returned with its original pouch batch 27836205.The returned device matches with upn provided by the customer.The returned guidewire was kinked at the distal tip section.Additionally, the core wire was exposed due to peeling of the polymer jacket and was detached at the distal tip.The peeled section related to the polymer was measured and 1.2cm was missing.Microscopic inspection revealed the distal tip was bent and the polymer peeled and detached.The very tip is without detachment or an exposed tip.The device was measured in three sections, and was within specification.
Event or Problem Description
It was reported that guidewire tip detachment occurred.Physician was performing a lower extremity pulmonary vein isolation (pvi).A 300cm, 12cm v-18 control wire was used to cross the lesion.However, during the procedure, the tip of the guidewire was fractured.The device was then removed but the tip was retained in the vessel.The detached tip could not be retrieved.No patient complications were reported after the tip detachment and the patient fully recovered.

• Brand Name: V-18 CONTROL WIRE
• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13334089
• Report Number: 2134265-2022-00252
• Device Sequence Number: 19244531
• Product Code: DQX
• UDI-Device Identifier: 08714729070238
• UDI-Public: 08714729070238
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K033742
• 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): 02/15/2022

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: 08/13/2023
• Device Model Number: 40535
• Device Catalogue Number: 40535
• Device Lot Number: 0027836205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/30/2021
• Supplement Date Received by Manufacturer: 01/25/2022
• Initial Report FDA Received Date: 01/24/2022
• Supplement Report FDA Received Date: 02/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2021
• 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: Unknown