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

Model Number	40458
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	01/20/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that guidewire tip detachment occurred.A 300cm straight tip v-14 control wire was advanced, however, the tip came off.No attempt to remove the detached fragment as it was in the plaque along the artery.The procedure was completed with two non-bsc guidewires.No patient complications were reported and patient status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: the guidewire was returned with its original pouch.The guidewire was easily removed from the hoop.The distal tip of the guidewire had the polymer detached; the damaged section was located approximately at 299 cm from the proximal end.The detached section was not returned.The distal tip was kinked approximately at 298 cm from the proximal end.No more damages were found in the device.The outer diameter of the middle and proximal sections are within specification; however, the overall length and outer diameter of the distal tip could not be performed due to device condition (polymer tip detached).
Event or Problem Description
It was reported that guidewire tip detachment occurred.A 300cm straight tip v-14 control wire was advanced, however, the tip came off.No attempt to remove the detached fragment as it was in the plaque along the artery.The procedure was completed with two non-bsc guidewires.No patient complications were reported and 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: 9688109
• Report Number: 2134265-2020-01103
• Device Sequence Number: 3603012
• Product Code: DQX
• UDI-Device Identifier: 08714729799269
• UDI-Public: 08714729799269
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 03/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/29/2021
• Device Model Number: 40458
• Device Catalogue Number: 40458
• Device Lot Number: 0024518200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2020
• Initial Date Received by Manufacturer: 01/20/2020
• Supplement Date Received by Manufacturer: 02/25/2020
• Initial Report FDA Received Date: 02/10/2020
• Supplement Report FDA Received Date: 03/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other