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

Model Number	40458
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	07/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that distal tip detachment occurred.The 90% stenosed target lesion was located in the non-tortuous posterior tib vessel.A 300cm straight tip v-14 control wire was selected for use.However, while trying to navigate the wire into the vessel, the soft tip part of the wire partially sheared off.The physician was able to place a non-boston scientific catheter beyond the separation and retrieve the wire without losing the wire access to the vessel and without harming the patient.All parts of the wire were still intact; and was confirmed through fluoroscopy that nothing was left inside the patient's body.The procedure was then completed using an alternate device.No patient complications were reported.
Event or Problem Description
It was reported that distal tip detachment occurred.The 90% stenosed target lesion was located in the non-tortuous posterior tib vessel.A 300cm straight tip v-14 control wire was selected for use.However, while trying to navigate the wire into the vessel, the soft tip part of the wire partially sheared off.The physician was able to place a non-boston scientific catheter beyond the separation and retrieve the wire without losing the wire access to the vessel and without harming the patient.All parts of the wire were still intact; and was confirmed through fluoroscopy that nothing was left inside the patient's body.The procedure was then completed using an alternate device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for the analysis, and it was observed that the guidewire was bent and detached at the distal section.The part detached was returned.The distance of the guidewire is 2,98 mts and the part detached distance is 2 cm.The pouch was returned, and it was observed that the pouch information matches with the complaint information.No more damages or issues were observed.

• 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 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: 17558804
• Report Number: 2124215-2023-40719
• Device Sequence Number: 3626841
• Product Code: DQX
• UDI-Device Identifier: 08714729799269
• UDI-Public: 08714729799269
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K112745
• 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): 10/09/2023

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: 03/12/2025
• Device Model Number: 40458
• Device Catalogue Number: 40458
• Device Lot Number: 0031226289
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/24/2023
• Supplement Date Received by Manufacturer: 09/13/2023
• Initial Report FDA Received Date: 08/16/2023
• Supplement Report FDA Received Date: 10/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2023
• 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
• Patient Sex: Unknown