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

Model Number	40495
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the guidewire distal tip detached.A v-18 control wire was selected for use in recanalization procedure of the anterior tibial artery.During the recanalization, resistance was noted when retracting the v-18 control wire into the balloon catheter.While withdrawing both the balloon and v-18 control wire, the distal tip of the v-18 control wire detached but remained inside the balloon catheter.Both devices were removed together.The procedure was completed using an alternative device.There were no patient complications.
Additional Manufacturer Narrative
D4 - lot number: updated.
Event or Problem Description
It was reported that the guidewire distal tip detached.A v-18 control wire was selected for use in recanalization procedure of the anterior tibial artery.During the recanalization, resistance was noted when retracting the v-18 control wire into the balloon catheter.While withdrawing both the balloon and v-18 control wire, the distal tip of the v-18 control wire detached but remained inside the balloon catheter.Both devices were removed together.The procedure was completed using an alternative device.There were no patient complications.
Event or Problem Description
It was reported that the guidewire distal tip detached.A v-18 control wire was selected for use in recanalization procedure of the anterior tibial artery.During the recanalization, resistance was noted when retracting the v-18 control wire into the balloon catheter.While withdrawing both the balloon and v-18 control wire, the distal tip of the v-18 control wire detached but remained inside the balloon catheter.Both devices were removed together.The procedure was completed using an alternative device.There were no patient complications.
Additional Manufacturer Narrative
Device eval by mfr: the device was returned, and technical analysis was completed on 25jul2023.The device was returned for the analysis, and it was observed that the guidewire was bent at the middle and distal tip section.It was observed that the polymer jacket was detached.Microscopic examination revealed the polymer jacket was detached.Inspection of the remainder of the device revealed no other damage or irregularities.

• 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: 17111080
• Report Number: 2124215-2023-29789
• Device Sequence Number: 11306204
• Product Code: DQX
• UDI-Device Identifier: 08714729070191
• UDI-Public: 08714729070191
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/16/2023

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: 03/15/2025
• Device Model Number: 40495
• Device Catalogue Number: 40495
• Device Lot Number: 0031245469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/05/2023
• Supplement Date Received by Manufacturer: 06/16/2023; 07/25/2023
• Initial Report FDA Received Date: 06/12/2023
• Supplement Report FDA Received Date: 07/10/2023; 08/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2023
• 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