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

Model Number	1006
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that tip detachment occurred, requiring snare for removal.The target lesion was located in the severely tortuous and severely calcified tibial vessels.A savion flx guidewire was selected for right lower extremity arteriogram.During the procedure, the physician attempted to cross the tortuous anatomy at the patient's dorsalis pedis or loop artery.However, while crossing the wire through the artery, the distal end of the guidewire tip broke off and detached from the remaining wire end.The physician had to use a snare device to capture the broken tip of the wire and remove it from the patient's artery.The procedure was completed using a non-boston scientific (bsc) guidewire.No patient complications were reported.
Event or Problem Description
It was reported that tip detachment occurred, requiring snare for removal.The target lesion was located in the severely tortuous and severely calcified tibial vessels.A savion flx guidewire was selected for right lower extremity arteriogram.During the procedure, the physician attempted to cross the tortuous anatomy at the patient's dorsalis pedis or loop artery.However, while crossing the wire through the artery, the distal end of the guidewire tip broke off and detached from the remaining wire end.The physician had to use a snare device to capture the broken tip of the wire and remove it from the patient's artery.The procedure was completed using a non-boston scientific (bsc) guidewire.No patient complications were reported.It was further reported that the correct device used in the procedure was v-14 control wire.The savion flx guidewire was not used in the procedure.
Additional Manufacturer Narrative
B5.Describe event or problem: added information, based on additional information.
Additional Manufacturer Narrative
Detailed product information was not provided to bsc.Gfe was completed and further product information was not known.Because the product information is unknown, we are unable to provide the unique identifier (udi) # and other specific product information.If additional details become available, a supplemental report will be submitted.Device evaluated by mfr: the v-14 control wire was returned to our post market quality assurance laboratory.Visual inspection was performed, and it was observed that it was detached and bent at distal tip.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that tip detachment occurred, requiring snare for removal.The target lesion was located in the severely tortuous and severely calcified tibial vessels.A savion flx guidewire was selected for right lower extremity arteriogram.During the procedure, the physician attempted to cross the tortuous anatomy at the patient's dorsalis pedis or loop artery.However, while crossing the wire through the artery, the distal end of the guidewire tip broke off and detached from the remaining wire end.The physician had to use a snare device to capture the broken tip of the wire and remove it from the patient's artery.The procedure was completed using a non-boston scientific (bsc) guidewire.No patient complications were reported.It was further reported that the correct device used in the procedure was v-14 control wire.The savion flx guidewire was not used in the procedure.

• Brand Name: V-14 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 DE COSTA RICA S.R.L.; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20334638
• Report Number: 2124215-2024-59442
• Device Sequence Number: 8097421
• Product Code: DQX
• UDI-Device Identifier: 08714729978817
• UDI-Public: 08714729978817
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K180726
• 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,Followup
• Report Date (Section B): 06/11/2025

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: 05/09/2026
• Device Model Number: 1006
• Device Catalogue Number: 1006
• Device Lot Number: 0034000561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2024
• Supplement Date Received by Manufacturer: 10/25/2024; 05/16/2025
• Initial Report FDA Received Date: 09/30/2024
• Supplement Report FDA Received Date: 11/19/2024; 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2024
• 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
• Patient Sex: Unknown