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

Model Number 40495

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/17/2024

Event Type  Injury  

Event Description

It was reported that the guidewire tip detached and could not be retrieved.The stenosed target lesion was located in the mildly tortuous and calcified tibial artery.A v-18 control wire was selected for use to treat chronic limb ischemia.During the procedure, it was noted that the tip of the wire detached while accessing the lesion in the tibial artery.The physician tried to snare the detached tip for removal, but it could not be removed.The physician decided to leave the detached tip inside the tibial artery.The procedure was completed using an alternate device.There were no patient complications reported.

• Brand Name: V-18 CONTROL WIRE
• Type of Device: 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18840149
• MDR Text Key: 336927507
• Report Number: 2124215-2024-13112
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 08714729070207
• UDI-Public: 08714729070207
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K033742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 40495
• Device Catalogue Number: 40495
• Device Lot Number: 0032261576
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other