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

Model Number	40495
Medical Device Problem Codes	Entrapment of Device (1212); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Extravasation (1842); Perforation (2001)
Date of Event	09/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that catheter entrapment occurred, causing perforation and the placement of a covered stent.The target lesion was located in the non-tortuous and moderately calcified left peroneal artery.An opticross 18 imaging catheter and a 200cm, 8cm v-18 control wire were selected for arterial intervention.During the procedure, the catheter became twisted and entangled with the wire, resulting in wire tip detachment.The physician could not remove the catheter from the wire, so both were taken out together.Consequently, contrast leaking was noted distal to the catheter, believing that the wire's movement might have caused a perforation in the peroneal artery.As a result, a covered stent was placed in the area of concern.The devices were completely removed from the patient's body, and the procedure was completed successfully.The patient fully recovered post-procedure.
Event or Problem Description
It was reported that catheter entrapment occurred, causing perforation and the placement of a covered stent.The target lesion was located in the non-tortuous and moderately calcified left peroneal artery.An opticross 18 imaging catheter and a 200cm, 8cm v-18 control wire were selected for arterial intervention.During the procedure, the catheter became twisted and entangled with the wire, resulting in wire tip detachment.The physician could not remove the catheter from the wire, so both were taken out together.Consequently, contrast leaking was noted distal to the catheter, believing that the wire's movement might have caused a perforation in the peroneal artery.As a result, a covered stent was placed in the area of concern.The devices were completely removed from the patient's body, and the procedure was completed successfully.The patient fully recovered post-procedure.It was further reported that the detached tip was noted upon removal.It came out with everything else.
Additional Manufacturer Narrative
B5.Describe event or problem: added information, based on additional information.

• Brand Name: V-18 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20433229
• Report Number: 2124215-2024-62371
• Device Sequence Number: 7860385
• Product Code: DQX
• UDI-Device Identifier: 08714729070191
• UDI-Public: 08714729070191
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/23/2026
• Device Model Number: 40495
• Device Catalogue Number: 40495
• Device Lot Number: 0033889182
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2024
• Supplement Date Received by Manufacturer: 10/18/2024
• Initial Report FDA Received Date: 10/11/2024
• Supplement Report FDA Received Date: 11/07/2024
• Date Device Manufactured: 04/23/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 86 YR
• Patient Sex: Male