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	No Consequences Or Impact To Patient (2199)
Date of Event	10/01/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that guide wire tip detachment occurred.The target lesion was located in the anterior tibial artery.A 300cm v-14 control wire was advanced into the target lesion.However, the tip broke off and the physician added an hour of work time to retrieve the detached tip using a snaring device.Catheterization was continued using a different wire and the procedure was completed.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.:initial condition of the unit returned with its original box, overall visual revision did not identify failures or evidence that could be lost due to decontamination process.Visual inspection was performed.A section of the polymer tip was detached; the damaged section was located approximately at 298.5 cm from the proximal end; the detached section of the device was not returned.No more damages were found in the device.Dimensional inspection was performed and the overall length could not be preformed due to the condition of the device as the tip was detached.The o.D.Was measured within specification.
Event or Problem Description
It was reported that guide wire tip detachment occurred.The target lesion was located in the anterior tibial artery.A 300cm v-14 control wire was advanced into the target lesion.However, the tip broke off and the physician added an hour of work time to retrieve the detached tip using a snaring device.Catheterization was continued using a different wire and the procedure was completed.No patient complications were reported.It was further reported that the target lesion was moderately calcified with approximately 80% stenosis.

• 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: 9195155
• Report Number: 2134265-2019-12435
• Device Sequence Number: 14367539
• Product Code: DQX
• UDI-Device Identifier: 08714729799276
• UDI-Public: 08714729799276
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 10/25/2019

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 Model Number: 40458
• Device Catalogue Number: 40458
• Device Lot Number: 0024252344
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2019
• Initial Date Received by Manufacturer: 10/01/2019
• Supplement Date Received by Manufacturer: 10/14/2019
• Initial Report FDA Received Date: 10/15/2019
• Supplement Report FDA Received Date: 10/25/2019
• 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: Required Intervention
• Patient Age: 45 YR