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

Model Number	40456
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that tip detachment occurred.A 300cm angled tip v-14 control wire was selected for use.However, when the physician pulled the guidewire out of the catheter, the tip was all coiled up and broke off.The tip portion of the device was already outside of the body at the time of fracture.The procedure was completed with a different device.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
B5.Describe event or problem updated.
Event or Problem Description
It was reported that tip detachment occurred.A 300cm angled tip v-14 control wire was selected for use.However, when the physician pulled the guidewire out of the catheter, the tip was all coiled up and broke off.The tip portion of the device was already outside of the body at the time of fracture.The procedure was completed with a different device.There were no patient complications nor injuries reported.It was further reported that the surgeon noted that the tibial vessel in which he was attempting to traverse was extremely calcified and that the tip began to detach from the body of the guide wire due to it becoming fixed in the calcium.The guide wire was removed completely into the diagnostic catheter before the tip completely detached for the wire body.The entire wire/tip and catheter were removed and the tip completely detached in the catheter during this process.
Additional Manufacturer Narrative
Device eval by mfr: the returned device matches with upn provided by the customer.Guidewire was visually inspected, and it was noticed that distal tip was kinked and the polymer jacket was detached from the distal tip section, the polymer section detached was returned with the device.No more visual damages were found in the device.Distal tip kinked and polymer jacket detached was confirmed under microscope inspection.
Event or Problem Description
It was reported that tip detachment occurred.A 300cm angled tip v-14 control wire was selected for use.However, when the physician pulled the guidewire out of the catheter, the tip was all coiled up and broke off.The tip portion of the device was already outside of the body at the time of fracture.The procedure was completed with a different device.There were no patient complications nor injuries reported.It was further reported that the surgeon noted that the tibial vessel in which he was attempting to traverse was extremely calcified and that the tip began to detach from the body of the guide wire due to it becoming fixed in the calcium.The guide wire was removed completely into the diagnostic catheter before the tip completely detached for the wire body.The entire wire/tip and catheter were removed and the tip completely detached in the catheter during this process.

• Brand Name: V-14 CONTROL WIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12737970
• Report Number: 2134265-2021-13344
• Device Sequence Number: 4127409
• Product Code: DQX
• UDI-Device Identifier: 08714729799238
• UDI-Public: 08714729799238
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/27/2021

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: 04/22/2023
• Device Model Number: 40456
• Device Catalogue Number: 40456
• Device Lot Number: 0027187753
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/15/2021
• Supplement Date Received by Manufacturer: 11/04/2021; 12/08/2021
• Initial Report FDA Received Date: 11/02/2021
• Supplement Report FDA Received Date: 11/24/2021; 12/27/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2021
• 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