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

Model Number	40456
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	03/15/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that detachment of device occurred.The target lesion was located in am arteriovenous (av) fistula.A 182cm straight tip v-14 control wire was selected for use.During the procedure upon removal, the tip became detached/stripped.Part of the guidewire remained in the patient's body.The procedure was completed with another device.There were no further patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: visual analysis of the returned device revealed the wire had tip damage.It was found the distal tip was peeled and kinked.Additionally, the polymer tip of the device was detached.There was evidence of polymer in the rest of the wire.The overall length and outer diameter of distal tip, middle of the device, and proximal section were within specifications.Inspection of the remainder of the device presented no other damages or irregularities.
Event or Problem Description
It was reported that detachment of device occurred.The target lesion was located in am arteriovenous (av) fistula.A 182cm straight tip v-14 control wire was selected for use.During the procedure upon removal, the tip became detached/stripped.Part of the guidewire remained in the patient's body.The procedure was completed with another device.There were no further patient complications reported.

• 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: 8492549
• Report Number: 2134265-2019-03601
• Device Sequence Number: 11204366
• Product Code: DQX
• UDI-Device Identifier: 08714729799207
• UDI-Public: 08714729799207
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K112745
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2019

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: 07/22/2020
• Device Model Number: 40456
• Device Catalogue Number: 40456
• Device Lot Number: 0022414995
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2019
• Initial Date Received by Manufacturer: 03/21/2019
• Supplement Date Received by Manufacturer: 05/14/2019
• Initial Report FDA Received Date: 04/08/2019
• Supplement Report FDA Received Date: 05/28/2019
• 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