MAUDE Adverse Event Report: VASCULAR SOLUTIONS, LLC VARI-LASE PLATINUM BRITE TIP; VARI-LASE PLATINUM BRIGHT TIP LASER FIBER

Model Number	7172
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There was no product returned for this complaint.No returned product evaluation could be completed.Pictures were provided of the device and the separated platinum tip.The event description states the platinum tip of the fiber separated inside the patient during use.A manufacturing record review was completed and no related non-conformances were found.A returned product evaluation was not completed as the product was discarded at the site.All inspections completed per process were reviewed and found to have passed.Without the device returning for evaluation it is undeterminable what may have caused the failure.
Event or Problem Description
As reported: the metal tip of the laser fiber went missing when the consultant removed the fiber after the evlt procedure on the 2nd leg (right side) scheduled for bilateral evlt using varilase platinum bright tip laser fiber with lot number 707549 and ref component #7147c.Packaging model # 7172.Xray was done to confirm the location of the metal tip which was found on the right leg and extracted with minimized skin incision.During the process of removal, the tip was crushed but was removed completely as confirmed by xray.There were no further problems during the procedure.A full length compression bandage was applied and the patient went home the same day.

• Brand Name: VARI-LASE PLATINUM BRITE TIP
• Common Device Name: VARI-LASE PLATINUM BRIGHT TIP LASER FIBER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 12061424
• Report Number: 2134812-2021-00049
• Device Sequence Number: 4110633
• Product Code: GEX
• UDI-Device Identifier: 10841156101008
• UDI-Public: (01)10841156101008
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K091551
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/07/2022
• Device Model Number: 7172
• Device Lot Number: 707549
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2021
• Initial Report FDA Received Date: 06/24/2021
• 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: 46 YR