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

Model Number	40495
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	04/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that tip detachment occurred.The target lesion was located in the left lower extremity.A 150cm, 8cm v-18 control wire guidewire was selected for use along with a 5fr non-boston scientific catheter.During the procedure, the physician was trying to cross the device into the lesion when the tip was sheared off and lodged in the superior left iliac artery.The tip was snared out and all parts were removed from the patient.The procedure was completed using an alternate device.No patient complications were reported.
Event or Problem Description
It was reported that tip detachment occurred.The target lesion was located in the left lower extremity.A 150cm, 8cm v-18 control wire guidewire was selected for use along with a 5fr non-boston scientific catheter.During the procedure, the physician was trying to cross the device into the lesion when the tip was sheared off and lodged in the superior left iliac artery.The tip was snared out and all parts were removed from the patient.The procedure was completed using an alternate device.No patient complications were reported.It was further reported that the vessel was heavily calcified.The patient was given 3000 units of heparin prior to attempting to cross the lesion.The wire was flushed in the protective coil prior to insertion with 2 units/ml heparinized saline.While trying to cross the lesion, resistance was encountered.

• 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: 19367250
• Report Number: 2124215-2024-29743
• Device Sequence Number: 20436916
• Product Code: DQX
• UDI-Device Identifier: 08714729070184
• UDI-Public: 08714729070184
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: NH
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2024

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: 06/05/2025
• Device Model Number: 40495
• Device Catalogue Number: 40495
• Device Lot Number: 0031767721
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2024
• Supplement Date Received by Manufacturer: 05/15/2024
• Initial Report FDA Received Date: 05/21/2024
• Supplement Report FDA Received Date: 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CATHETER: CORDIS 5 FR; CATHETER: CORDIS 5 FR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown