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

Model Number	40456
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device entrapment occurred.The patient presented with tibial artery blockage and underwent balloon angioplasty.After gaining vascular access via the femoral artery, a 3.0mm x 80mm x 150cm coyote balloon catheter was advanced for dilatation.However, during introduction, the balloon got stuck on a 300cm angled tip v-14 control wire guidewire and would not move further into the target lesion.The device was removed and the procedure was completed with another of the same device.No patient complications were reported and the patient status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: the guidewire was returned stuck inside the coyote catheter.It is possible to observe that the distal tip and the proximal section is bent/kinked.The dimensions that could be measured were inspected and the outer diameter specifications passed inspection.
Event or Problem Description
It was reported that device entrapment occurred.The patient presented with tibial artery blockage and underwent balloon angioplasty.After gaining vascular access via the femoral artery, a 3.0mm x 80mm x 150cm coyote balloon catheter was advanced for dilatation.However, during introduction, the balloon got stuck on a 300cm angled tip v-14 control wire guidewire and would not move further into the target lesion.The device was removed, and the procedure was completed with another of same device.No patient complications were reported, and the patient status was stable.

• 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: 15976198
• Report Number: 2124215-2022-49597
• Device Sequence Number: 17607005
• Product Code: DQX
• UDI-Device Identifier: 08714729799238
• UDI-Public: 08714729799238
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2023

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: 04/22/2023
• Device Model Number: 40456
• Device Catalogue Number: 40456
• Device Lot Number: 0027187753
• 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: 11/22/2022
• Supplement Date Received by Manufacturer: 02/02/2023
• Initial Report FDA Received Date: 12/14/2022
• Supplement Report FDA Received Date: 02/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2021
• 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
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 68 KG