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

Model Number	40456
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Used (b)(6) 2019 as event date since the correct date was not provided.
Event or Problem Description
It was reported that guidewire fracture occurred.Vascular access was obtained from the right groin.The target lesion was located in the left proximal superficial femoral artery.After a 6fr non-bsc sheath was placed, a 182cm straight tip v-14 control wire guidewire was used to cross the lesion.However, when a non-bsc intravascular ultrasound (ivus) catheter was also advanced to the left iliac, the guidewire broke outside the patient.The procedure was completed with no issues.No patient complications were reported.
Event or Problem Description
It was reported that guidewire fracture occurred.Vascular access was obtained from the right groin.The target lesion was located in the left proximal superficial femoral artery.After a 6fr non-bsc sheath was placed, a 182cm straight tip v-14 control wire guidewire was used to cross the lesion.However, when a non-bsc intravascular ultrasound (ivus) catheter was also advanced to the left iliac, the guidewire broke outside the patient.The procedure was completed with no issues.No patient complications were reported.
Additional Manufacturer Narrative
Date of event- used (b)(6) 2019 as event date since the correct date was not provided.Device evaluated by mfr.: the device was returned for analysis.The guidewire received was found broken/fractured approximately at 50.5 cm from the proximal end.The other section measured approximately 130 cm from the distal tip.The device has the distal tip kinked and body kinked.No more damages were found in the device.Dimensional inspection of the overall length of the device and outer diameter of the distal tip could not be performed due to device condition.Outer diameter of middle and proximal section of the device are 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: 8776477
• Report Number: 2134265-2019-08015
• Device Sequence Number: 1904577
• Product Code: DQX
• UDI-Device Identifier: 08714729799207
• UDI-Public: 08714729799207
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K112745
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2019

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: 05/14/2021
• Device Model Number: 40456
• Device Catalogue Number: 40456
• Device Lot Number: 0023798420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2019
• Initial Date Received by Manufacturer: 06/26/2019
• Supplement Date Received by Manufacturer: 08/23/2019
• Initial Report FDA Received Date: 07/10/2019
• Supplement Report FDA Received Date: 09/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1