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 Consequences Or Impact To Patient (2199)
Date of Event	03/22/2019
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 target lesion was located in the abdominal aorta.A long taper 182cm straight tip v-14 control wire guidewire was selected for use.After the device was navigated to the lesion and attempted to rotate, it was noted that the guidewire broke into two pieces.The fracture point was outside the patient's body.The broken part of the device was completely removed from the patient's body and the procedure was completed with a different device.No patient serious injury or adverse event were reported and the patient's status was stable.
Event or Problem Description
It was reported that guidewire fracture occurred.The target lesion was located in the abdominal aorta.A long taper 182cm straight tip v-14 control wire guidewire was selected for use.After the device was navigated to the lesion and attempted to rotate, it was noted that the guidewire broke into two pieces.The fracture point was outside the patient's body.The broken part of the device was completely removed from the patient's body and the procedure was completed with a different device.No patient serious injury or adverse event were reported and the patient's status was stable.
Additional Manufacturer Narrative
Age at time of event: 18 years or older.Device evaluated by mfr.: the device was returned for analysis.The device had its middle section kinked.The device was broken 157 cm from the distal section to the broken section; the overall length should be 182 cm.The other part of the device was not returned.Additionally, the distal tip was severely kinked.The outer diameter of the distal tip and middle section were within specification.

• 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: 8487400
• Report Number: 2134265-2019-03528
• Device Sequence Number: 16816705
• Product Code: DQX
• UDI-Device Identifier: 08714729799245
• UDI-Public: 08714729799245
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K112745
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2019

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: 03/25/2020
• Device Model Number: 40458
• Device Catalogue Number: 40458
• Device Lot Number: 0021914040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2019
• Initial Date Received by Manufacturer: 03/22/2019
• Supplement Date Received by Manufacturer: 05/14/2019
• Initial Report FDA Received Date: 04/05/2019
• Supplement Report FDA Received Date: 05/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1