MAUDE Adverse Event Report: VASCULAR SOLUTIONS, LLC MICRO-INTRODUCER; INTRODUCER CATHETER

Model Number 7230X

Device Problems Fire (1245); Melted (1385)

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

Event Date 12/21/2018

Event Type  malfunction  

Manufacturer Narrative

The introducer sheath was returned for evaluation.The shaft of the 30cm sheath was separated approximately 10cm from the hub and the separation point was melted and stretched.Follow-up communication confirmed the laser fiber was not manufactured by vascular solutions and had separated while in use.The laser fiber was not returned for evaluation.The most likely cause for the event is the laser fiber broke inside of the sheath while activated, causing the release of energy in an unintended area.As a result, the shaft of the sheath melted causing it to separate outside the patient.

Event Description

When pulling back laser once outside the leg, the laser ignited, causing the sheath to start on fire.The sheath appeared to be separated about 10-11cm from the hub.It ignited outside of patient's leg.It was 10cm outside of leg when igniting.Physician was able to continue procedure with another fiber.Haven't done post op to ensure closure of vein yet.There was no reported impact to the patient.

• Brand Name: MICRO-INTRODUCER
• Type of Device: INTRODUCER CATHETER
• Manufacturer (Section D): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer (Section G): VASCULAR SOLUTIONS, LLC; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer Contact: mary haufek ; 6464 sycamore court north; minneapolis, MN 55369 ; 7636564230
• MDR Report Key: 8261793
• MDR Text Key: 133559860
• Report Number: 2134812-2019-00007
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180913
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/06/2020
• Device Model Number: 7230X
• Device Lot Number: 605081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 57 YR
• Patient Weight: 66