MAUDE Adverse Event Report: VASCULAR SOLUTIONS, LLC VARI-LASE KIT; LASER INSTRUMENT FIBER AND PROCEDURE KIT

Model Number 7174

Device Problem Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/03/2019

Event Type  Injury  

Manufacturer Narrative

Returned product evaluation was unable to be completed as the complaint device was not returned.A manufacturing record review was unable to be completed as the lot number is unknown.If further information is received, a follow-up report will be submitted.

Event Description

During an evlt (endovenous lazer treatment) laser fiber guidewire snapped at midway point during use on a patient.Current patient condition is reported as fine.Additional information has been requested, however, no response has been received.Medical intervention was reported.

Manufacturer Narrative

One vari-lase bright tip fiber was returned for evaluation.The guidewire did not return.The manufacturing record review was unable to be completed as the lot number was unknown.The unit was examined, and the fiber was found to be separated (not the guidewire, as reported).The separation was located 126.5cm from the distal tip of the fiber.No damage was found in relation to the fiber connector nor the fiber tip.An in-line proof test is performed by supplier on 100% of fibers; this screens out flaws that would lead to breaks.Several inspections are also completed at our manufacturing facility.It is therefore highly unlikely that this break is related to manufacturing.The ifu specifically instructs the user to carefully inspect the packaging and components for damage prior to use and precautions "do not use the vari-lase laser fiber if the packaging has been damaged." supplier was contacted in relation to this event and provided with pictures of the separation point.Supplier indicated the laser was likely not activated at the time of the breakage due to no signs of heat damage on the fiber.A break of the fiber in the middle of the unit is typically indicative of potential mishandling (either bending the fiber too right or a sharp impact on the jacket).However, it cannot be confirmed when the breakage could have occurred during handling nor if the unit was mishandled.The final cause is therefore undeterminable.

Event Description

Additional information received.Piece of guidewire was removed from the patient, it was withdrawn from the patient with the catheter and no other fragments were left in the patient.There was no injury reported to the patient.It is reported that the device was used per the ifu.The procedure was completed by using a second product.

• Brand Name: VARI-LASE KIT
• Type of Device: LASER INSTRUMENT FIBER AND PROCEDURE KIT
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• MDR Report Key: 8292497
• MDR Text Key: 134601894
• Report Number: 2134812-2019-00009
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• PMA/PMN Number: K091551
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 01/03/2019

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
• Device Operator: No Information
• Device Model Number: 7174
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/03/2019
• Initial Date FDA Received: 01/31/2019
• Supplement Dates Manufacturer Received: 01/03/2019
• Supplement Dates FDA Received: 03/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention