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	10/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Used (b)(6) 2018 as event date as there was no date provided.
Event or Problem Description
It was reported that guide wire tip detachment occurred.The target lesion was located in a vessel below the knee.A 300cm, 12cm v-18 control wire was advanced to the lesion.However, it was noted that the tip of the wire broke off while inside the patient's foot.No patient complications were reported and the patient's status was fine.
Additional Manufacturer Narrative
Event date: (b)(6) 2018.
Event or Problem Description
It was reported that guide wire tip detachment occurred.The target lesion was located in a vessel below the knee.A 300cm, 12cm v-18 control wire was advanced to the lesion.However, it was noted that the tip of the wire broke off while inside the patient's foot.No patient complications were reported and the patient's status was fine.It was further reported that the target lesion was located in the right anterior tibial artery.The procedure performed was for a retrograde cannulation.After the tip broke, the surgeon decided that the tip would be left in place.

• 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: 8165272
• Report Number: 2134265-2018-64234
• Device Sequence Number: 2745405
• Product Code: DQX
• UDI-Device Identifier: 08714729070238
• UDI-Public: 08714729070238
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2019

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: 08/07/2020
• Device Model Number: 40535
• Device Catalogue Number: 40535
• Device Lot Number: 0022485383
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/03/2018
• Supplement Date Received by Manufacturer: 04/22/2019
• Initial Report FDA Received Date: 12/14/2018
• Supplement Report FDA Received Date: 05/09/2019
• 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
• Patient Age: 87 YR
• Patient Weight: 127