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

Model Number	40456
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that coating issue occurred and the procedure was cancelled.The patient was scheduled for arteriography plus lower limb angioplasty.The 70% stenosed target lesion was located in mildly tortuous and mildly/moderately calcified lower limb.A short taper 300cm angled tip v-14 control wire was used with a non-boston scientific support catheter during the procedure.However, the guidewire lost it's hydrophilic coating, so it did not navigate.The entire system was removed, and the guidewire was observed with a high potential of tip detachment.The procedure was not completed.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: unit returned overall visual revision the unit returned kinked.The device was returned, and it was observed that the distal section of the guidewire was bent/kinked.The distal tip was detached, and the coating was separated at the distal section.The pouch was returned, and it was observed that the pouch information matches with the complaint information.Under the microscope was the distal tip was detached, and the coating was separated.Boston scientific manufacturing processes include extensive inspections to ensure that all finished devices meet specifications.
Event or Problem Description
It was reported that coating issue occurred, and the procedure was cancelled.The patient was scheduled for arteriography plus lower limb angioplasty.The 70% stenosed target lesion was located in mildly tortuous and mildly/moderately calcified lower limb.A short taper 300cm angled tip v-14 control wire was used with a non-boston scientific support catheter during the procedure.However, the guidewire lost its hydrophilic coating, so it did not navigate.The entire system was removed, and the guidewire was observed with a high potential of tip detachment.The procedure was not completed.There were no patient complications 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 15829544
• Report Number: 2124215-2022-45431
• Device Sequence Number: 5316554
• Product Code: DQX
• UDI-Device Identifier: 08714729799238
• UDI-Public: 08714729799238
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/08/2024
• Device Model Number: 40456
• Device Catalogue Number: 40456
• Device Lot Number: 0029554782
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/28/2022
• Supplement Date Received by Manufacturer: 03/30/2023
• Initial Report FDA Received Date: 11/18/2022
• Supplement Report FDA Received Date: 04/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2022
• 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
• Patient Sex: Unknown