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

Model Number ASKU

Device Problem Material Fragmentation (1261)

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

Event Date 01/20/2017

Event Type  Injury  

Manufacturer Narrative

The event description states that the patient returned for a follow up and the tip of the laser was still in the patient, tip was removed in the clinic.There is no product information, model number, lot number or returned product to complete an evaluation.The root cause is undeterminable.

Event Description

About 2 months ago, physician used a vari-lase laser on a patient, not sure which model, the patient returned for a follow up about two weeks ago and the tip of the laser was still in the patient.The doctor was able to remove the tip in the clinic and the patient is doing fine.There is no product to return or photo documentation.Procedure occurred approximately 2 months before the physician realized the fiber tip was left in the patient.They do not have record of the model #, p/n or lot # of the product.

• Brand Name: VARI-LASE KIT
• Type of Device: LASER INSTRUMENT FIBER AND PROCEDURE KIT
• Manufacturer (Section D): VASCULAR SOLUTIONS, INC.; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer (Section G): VASCULAR SOLUTIONS, INC.; 6464 sycamore court north; minneapolis MN 55369
• Manufacturer Contact: mary haufek ; 6464 sycamore court north; minneapolis, MN 55369 ; 7636564230
• MDR Report Key: 6456528
• MDR Text Key: 71616484
• Report Number: 2134812-2017-00038
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• 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: 03/10/2017

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 Model Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/10/2017
• Initial Date FDA Received: 04/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention