MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION V-14 CONTROL WIRE; WIRE, GUIDE, CATHETER

Model Number	40458
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/27/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that tip detached and remained in the patient.A 300cm straight tip v-14 control wire guidewire was advanced for treatment.However, tip of the wire came off inside the vessel and the tip became lodged in the plaque and could not be retrieved.No further patient complications reported.
Event or Problem Description
It was reported that tip detached and remained in the patient.A 300cm straight tip v-14 control wire guidewire was advanced for treatment.However, tip of the wire came off inside the vessel and the tip became lodged in a plaque and could not be retrieved.No further patient complications reported.It was further reported that the 100% stenosed target lesion was located in the tibial artery.The detached wire tip was in unreachable location and was subintimal so it could not be removed.The procedure was completed with non-bsc device.No patient complications were reported.
Additional Manufacturer Narrative
Updated b5 and event date.
Additional Manufacturer Narrative
Device evaluated by mfr: initial condition: the device was returned for analysis, overall visual revision did not identify failures or evidence that could be lost due to decontamination process.The returned device matches with upn provided by the customer.The guidewire returned with its original opened pouch.The returned guidewire had the distal tip damaged; the polymer tip showed a separated section and it was not returned.The separated section was located approximately at 299.7 cm from the proximal end.The distal tip was found bent.The body was kinked approximately at 145 cm from the proximal end.No more visual damages were found in the device.Detailed pictures of the damaged area were captured.The outer diameter of the middle and proximal sections of the device are within specifications.
Event or Problem Description
It was reported that tip detached and remained in the patient.A 300cm straight tip v-14 control wire guidewire was advanced for treatment.However, tip of the wire came off inside the vessel and the tip became lodged in a plaque and could not be retrieved.No further patient complications reported.It was further reported that the 100% stenosed target lesion was located in the tibial artery.The detached wire tip was in unreachable location and was subintimal so it could not be removed.The procedure was completed with non-bsc device.No patient complications were reported.

• Brand Name: V-14 CONTROL WIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9920597
• Report Number: 2134265-2020-04359
• Device Sequence Number: 16961872
• Product Code: DQX
• UDI-Device Identifier: 08714729799269
• UDI-Public: 08714729799269
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K112745
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/27/2020

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: 02/26/2021
• Device Model Number: 40458
• Device Catalogue Number: 40458
• Device Lot Number: 0023410979
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2020
• Initial Date Received by Manufacturer: 03/27/2020
• Supplement Date Received by Manufacturer: 04/07/2020; 05/21/2020
• Initial Report FDA Received Date: 04/03/2020
• Supplement Report FDA Received Date: 04/14/2020; 05/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention