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

Model Number	40456
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)
Date of Event	10/07/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that coating issue was encountered.The target lesion was located in the anterior tibial artery.A 300cm angled tip v-14 control wire guidewire was advanced to the lesion.However, when attempting to cross the lesion, and pulling the wire back to find a better channel in the lesion to cross, the coating at the tip was pulled off of the wire.The procedure was completed with a different device.No patient complications were reported.
Event or Problem Description
It was reported that coating issue was encountered.The target lesion was located in the anterior tibial artery.A 300cm angled tip v-14 control wire guidewire was advanced to the lesion.However, when attempting to cross the lesion and pulling the wire back to find a better channel in the lesion to cross, the coating at the tip was pulled off of the wire.The procedure was completed with a different device.No patient complications were reported.It was further reported that the target lesion had 95% stenosis located in the highly calcified and moderately tortuous anterior tibial artery.The device was pulled out by snaring.The covering was not recovered because it posed a greater threat to the patient than leaving it in the occluded vessel.The patient was unharmed.The patient showed no adverse effect in or and was transported to pacu without issue.
Event or Problem Description
It was reported that coating issue was encountered.The target lesion was located in the anterior tibial artery.A 300cm angled tip v-14 control wire guidewire was advanced to the lesion.However, when attempting to cross the lesion and pulling the wire back to find a better channel in the lesion to cross, the coating at the tip was pulled off of the wire.The procedure was completed with a different device.No patient complications were reported.It was further reported that the target lesion had 95% stenosis located in the highly calcified and moderately tortuous anterior tibial artery.The device was pulled out by snaring.The covering was not recovered because it posed a greater threat to the patient than leaving it in the occluded vessel.The patient was unharmed.The patient showed no adverse effect in or and was transported to pacu without issue.
Additional Manufacturer Narrative
Device evaluation by mfr: the returned device matches with upn and lot provided by the customer.The returned guidewire had a section of the polymer tip detached and not returned.The device was measured in three sections (distal - medium - proximal) along it in order to confirm that is within specification.

• 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: 10711595
• Report Number: 2134265-2020-14475
• Device Sequence Number: 3281198
• Product Code: DQX
• UDI-Device Identifier: 08714729799238
• UDI-Public: 08714729799238
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K112745
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/08/2020

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: 08/10/2022
• Device Model Number: 40456
• Device Catalogue Number: 40456
• Device Lot Number: 0025839878
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Initial Date Received by Manufacturer: 10/08/2020
• Supplement Date Received by Manufacturer: 10/21/2020; 12/01/2020
• Initial Report FDA Received Date: 10/21/2020
• Supplement Report FDA Received Date: 11/05/2020; 12/08/2020
• 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
• Patient Age: 65 YR