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

Model Number	40456
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that guidewire tip detachment occurred.The patient presented with peripheral arterial disease and underwent leg angioplasty.The 100% stenosed target lesion was located in the mildly tortuous and severely calcified vessel.A 300cm angled tip v-14 control wire was advanced.However, while crossing the lesion, the tip of the wire broke off in the distal tibia.Another guidewire was used to complete the procedure.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: unit returned with its original pouch, overall visual revision did not identify failures or evidence that could be lost due to decontamination process.Under visual and microscopic inspection, the device returned was observed to have distal tip detached, and it was observed that the wire kinked at the distal section.The pouch was returned, and it was observed that the pouch information matches with the complaint information.No more damages or issues were observed.Boston scientific manufacturing processes include extensive inspections to ensure that all finished devices meet specifications.
Event or Problem Description
It was reported that guidewire tip detachment occurred.The patient presented with peripheral arterial disease and underwent leg angioplasty.The 100% stenosed target lesion was located in the mildly tortuous and severely calcified vessel.A 300cm angled tip v-14 control wire was advanced.However, while crossing the lesion, the tip of the wire broke off in the distal tibia.Another guidewire was used to complete the procedure.No patient complications were reported.

• Brand Name: V-14 CONTROL WIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• 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: 16940727
• Report Number: 2124215-2023-20915
• Device Sequence Number: 7562524
• Product Code: DQX
• UDI-Device Identifier: 08714729799238
• UDI-Public: 08714729799238
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2023

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: 02/06/2025
• Device Model Number: 40456
• Device Catalogue Number: 40456
• Device Lot Number: 0031002321
• 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: 04/25/2023
• Supplement Date Received by Manufacturer: 05/31/2023
• Initial Report FDA Received Date: 05/16/2023
• Supplement Report FDA Received Date: 06/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2023
• 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