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

Model Number	40458
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that coating issue occurred.The target lesion was located in the tibial artery.A 300cm straight tip v-14 control wire guidewire was used.However, during the procedure, the coating of the tip peeled off and was retrieved by snaring.The procedure was completed with a non-boston scientific guidewire.
Additional Manufacturer Narrative
Device evaluated by mfr.: unit returned with its original box batch, overall visual revision did not identify failures or evidence that could be lost due to decontamination process.The device was received and the polymer jacket was detached from the distal tip and the distal section was kinked.No other issues were noted in the device.Under microscope was confirmed the polymer jacket was detached and the distal tip was kinked.The device was measured in three sections (distal - medium - proximal) along it in order to confirm that is within specification.The outer diameter of the distal, medium and proximal were within specifications.
Event or Problem Description
It was reported that coating issue occurred.The target lesion was located in the tibial artery.A 300cm straight tip v-14 control wire guidewire was used.However, during the procedure, the coating of the tip peeled off and was retrieved by snaring.The procedure was completed with a non-boston scientific guidewire.

• 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
• 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: 14804399
• Report Number: 2134265-2022-06717
• Device Sequence Number: 4879731
• Product Code: DQX
• UDI-Device Identifier: 08714729799269
• UDI-Public: 08714729799269
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K112745
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2022

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: 11/19/2023
• Device Model Number: 40458
• Device Catalogue Number: 40458
• Device Lot Number: 0028418571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/03/2022
• Supplement Date Received by Manufacturer: 07/28/2022
• Initial Report FDA Received Date: 06/24/2022
• Supplement Report FDA Received Date: 08/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2021
• 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
• Patient Race: Asian