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

Model Number 7106

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/27/2015

Event Type  Injury  

Event Description

Upon completion of an endovenous laser ablation procedure, it was noticed that the distal tip of the laser fiber was missing.The tip was located in the patients leg approximately 2 cm from the puncture site and removed through a surgical incision.No further patient impact was reported.

• Brand Name: VARI-LASE 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: 5251225
• MDR Text Key: 32194549
• Report Number: 2134812-2015-00040
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K070216
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/25/2015

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: Physician
• Device Expiration Date: 07/31/2016
• Device Model Number: 7106
• Device Lot Number: 574888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2015
• Initial Date Manufacturer Received: 10/28/2015
• Initial Date FDA Received: 11/25/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/11/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention