MAUDE Adverse Event Report: VASCULAR SOLUTIONS, INC. VARI-LASE PLATINUM BRIGHT TIP PROCEDURE KIT; LASER INSTRUMENT FIBER AND PROCEDURE KIT

Model Number 7159

Device Problem Material Fragmentation (1261)

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

Event Date 12/28/2015

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

During an ultrasound followup appointment two weeks after an endovenous laser ablation procedure, the physician noticed a small piece of the laser fiber tip in the ablated vein.No impact to the patient was reported as a result of the fiber tip being left in the ablated vein and no followup procedure was performed.

• Brand Name: VARI-LASE PLATINUM BRIGHT TIP PROCEDURE KIT
• Type of Device: LASER INSTRUMENT FIBER AND PROCEDURE KIT
• Manufacturer (Section D): VASCULAR SOLUTIONS, INC.; 6464 sycamore court north; maple grove MN 55369
• Manufacturer Contact: paul campbell ; 6464 sycamore court north; maple grove, MN 55369 ; 7637622560
• MDR Report Key: 5429316
• MDR Text Key: 37974753
• Report Number: 2134812-2016-00007
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091551
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/10/2016

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
• Device Operator: Physician
• Device Expiration Date: 08/31/2017
• Device Model Number: 7159
• Device Lot Number: 589846
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2016
• Initial Date FDA Received: 02/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other