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

Model Number 7172

Device Problem Material Fragmentation (1261)

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Date 09/24/2018

Event Type  Injury  

Manufacturer Narrative

The complaint received is in regard to a guidewire separation.The guidewire was returned to for evaluation and the complaint was confirmed.The core wire and outer coil were broken, causing distal section of the wire to separate.The outer coil was stretched and unraveled from the core wire.The guidewire was curled near the point of separation and the break point was a sharp point.Wire was sent out to the supplier for additional investigation.If further information is received a follow-up report will be submitted.

Event Description

The guidewire snapped inside the patient's long saphenous vein during use, and then had to be manually retrieved.Additional information received (b)(6) 2018: the guidewire was manually removed, open cut down under x-ray guidance, and ultrasound.Lot number of kit is unknown.

Manufacturer Narrative

Investigation from supplier reports the complaint was confirmed.These wires are submitted to incoming inspections and from the device history record (dhr) review, the pull tests for distal tip ball weld and tensile pull force of the ball weld shows all samples passed inspection criteria.The returned device has a bend on the wire, indicating it may have been submitted to improper clinical insertion technique.The wire bullet shape and ball weld were intact.The wire was tangled and the curling of coiled parts could have been caused by pulling the wire while the needle was in position.

• 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: 8004134
• MDR Text Key: 124953157
• Report Number: 2134812-2018-00076
• 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,health
• Type of Report: Initial,Followup
• Report Date: 09/25/2018

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: Health Professional
• Device Model Number: 7172
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2018
• Initial Date Manufacturer Received: 09/25/2018
• Initial Date FDA Received: 10/25/2018
• Supplement Dates Manufacturer Received: 09/25/2018
• Supplement Dates FDA Received: 11/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 52