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

Model Number	40458
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
It was reported that guidewire fracture occurred.The chronic totally occluded lesion was located in a severely tortuous and severely calcified vessel near the ankle.A 300cm straight tip v-14 control wire guidewire was advanced but it became fractured, although still connected.The procedure was completed with another of same device.There were no complications reported and the patient status was stable.
Additional Manufacturer Narrative
A2.Age at time of event: 18 years or older.Device evaluated by mfr: unit returned with its original pouch batch (b)(6).The returned device matches with upn provided by the customer.Visual inspection revealed a damaged tip.A section of the polymer jacket was peeled from the tip at the distal section and the wire was found kinked at the tip.No other issues were noted in the device.Under microscope it was confirmed the polymer jacket was peeled from the tip and the wire was kinked at the tip section.The polymer is covered the very tip.The device was measured in three sections (distal - medium - proximal) and confirmed it was within specification.
Event or Problem Description
It was reported that guidewire fracture occurred.The chronic totally occluded lesion was located in a severely tortuous and severely calcified vessel near the ankle.A 300cm straight tip v-14 control wire guidewire was advanced but it became fractured, although still connected.The procedure was completed with another of same device.There were no complications reported and the patient status was stable.

• 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
• MDR Report Key: 12264031
• Report Number: 2134265-2021-09666
• Device Sequence Number: 4066799
• Product Code: DQX
• UDI-Device Identifier: 08714729799269
• UDI-Public: 08714729799269
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2021

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: 07/15/2022
• Device Model Number: 40458
• Device Catalogue Number: 40458
• Device Lot Number: 0025721686
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2021
• Initial Date Received by Manufacturer: 07/15/2021
• Supplement Date Received by Manufacturer: 08/30/2021
• Initial Report FDA Received Date: 08/02/2021
• Supplement Report FDA Received Date: 09/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1