MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION V-18 CONTROL WIRE; WIRE, GUIDE, CATHETER

Model Number	40535
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	06/17/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that tip detachment occurred.The target lesion was located in the left posterior tibial artery.A v-18, 300cm, 12cm poly tip control wire guidewire was selected for use.However, during procedure, the tip of the wire was caught on a calcium and sheered off.The detached tip was retrieved by snaring.The procedure was completed with another of the same device.No patient injury or adverse event were reported and patient was good.
Event or Problem Description
It was reported that tip detachment occurred.The target lesion was located in the left posterior tibial artery.A v-18, 300cm, 12cm poly tip control wire guidewire was selected for use.However, during procedure, the tip of the wire was caught on a calcium and sheered off.The detached tip was retrieved by snaring.The procedure was completed with another of the same device.No patient injury or adverse event were reported and patient was good.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device has its distal tip detached.The distal tip of the device has the polymer tip sheared and the detached section returned together with the device.The detached section was located approximately at 297 cm from the proximal end.The distal tip was kinked as well as the body, the kinked section of the body was located approximately at 136 cm and 260 cm from the proximal end.The outer diameter of the middle and proximal sections of the device are within specifications.

• Brand Name: V-18 CONTROL WIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8731765
• Report Number: 2134265-2019-07377
• Device Sequence Number: 2003758
• Product Code: DQX
• UDI-Device Identifier: 08714729070238
• UDI-Public: 08714729070238
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K033742
• 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): 08/22/2019

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: 05/09/2021
• Device Model Number: 40535
• Device Catalogue Number: 40535
• Device Lot Number: 0023773077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2019
• Initial Date Received by Manufacturer: 06/17/2019
• Supplement Date Received by Manufacturer: 08/07/2019
• Initial Report FDA Received Date: 06/25/2019
• Supplement Report FDA Received Date: 08/22/2019
• 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: 70 YR