MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION V-18 CONTROL WIRE; WIRE, GUIDE, CATHETER

Model Number	40585
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that guidewire entrapment occurred.The patient presented with vascular access failure and underwent vascular access intervention therapy.The 99% stenosed target lesion was located in a shunt in a mildly tortuous vessel.A 110cm, 8cm v-18 control wire guidewire was advanced.However, during repeated expansion, the balloon and guidewire got stuck around the hub.The device was removed together with the balloon and the procedure was completed.No patient complications nor injuries were reported.
Event or Problem Description
It was reported that guidewire entrapment occurred.The patient presented with vascular access failure and underwent vascular access intervention therapy.The 99% stenosed target lesion was located in a shunt in a mildly tortuous vessel.A 110cm, 8cm v-18 control wire guidewire was advanced.However, during repeated expansion, the balloon and guidewire got stuck around the hub.The device was removed together with the balloon and the procedure was completed.No patient complications nor injuries were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the guidewire was returned, and no damages were observed.The device was soaked in a saline solution in order to activate the coating on the distal section.When the coating was activated, no issues were identified in the distal tip coating.Microscopic inspection revealed no damages on the distal tip coating.Dimensional inspection of three sections (distal - medium - proximal) along the guidewire confirmed the dimensions were within specification.

• Brand Name: V-18 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: 15853298
• Report Number: 2124215-2022-46233
• Device Sequence Number: 6318065
• Product Code: DQX
• UDI-Device Identifier: 08714729715566
• UDI-Public: 08714729715566
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K033742
• 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): 01/03/2023

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: 03/07/2024
• Device Model Number: 40585
• Device Catalogue Number: 40585
• Device Lot Number: 0029006277
• 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: 11/02/2022
• Supplement Date Received by Manufacturer: 12/15/2022
• Initial Report FDA Received Date: 11/23/2022
• Supplement Report FDA Received Date: 01/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2022
• 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