MAUDE Adverse Event Report: VASCULAR SOLUTIONS, LLC VARI-LASE PT BRITE TIP; VARI-LASE PLATINUM BRIGHT TIP LASER FIBER

Model Number 7172

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/15/2019

Event Type  Injury  

Manufacturer Narrative

A manufacturing record review was unable to be completed as the lot number is unknown.As stated in the event description, only the distal tip section consisting of the glass fiber with the platinum sleeve attached was returned for evaluation.Charred blood was present on the tip, confirming use on a patient.Adhesive used to bond the platinum sleeve to the fiber was present, and the glass fiber extended to the distal end of the platinum sleeve.The fiber separation was located at the proximal end of the platinum sleeve.Based on the event details and the evaluation of the returned tip section, the fiber was likely pulled against resistance, which caused the glass to crack and separate at the observed location.

Event Description

Reported that "evla procedure was completed.As the physician removed the fiber from the patient's thigh, he felt a lot of resistance and had to 'slightly tug' the fiber to remove it.Upon removal, it was noted that the platinum tip was missing.Patient had an x-ray and the tip was in the fatty tissue in the patient's thigh.The surgeon was unable to remove it under la.A clinical decision was made, due to the location of the tip, the patient was sent home and will return to the hospital for removal under ga.Once the patient is recalled and the tip removed, it will be sent to the manufacturer for investigation.Additional information received 30may19: the initial intervention was carried out under ultrasound and tip could always be seen.Only when removing the device did the issue occur.We completed an x-ray which clearly show it to be in the fatty tissue, not in the vein post procedure.Consultant explained to patient what happened, and pt taken for x-ray.Acu manager - patient brought back to acu procedure room for exploratory surgery, could not retrieve missing item.Confirmed laser fiber tip not in vein, only in fatty tissue.Patient discharged then bought back to (b)(6) on (b)(6) 2019 for retrieval of tip.Procedure successful and patient returned to the ward.Nurse noticed hematoma and so taken back to acu for evacuation of hematoma.Patient went home later the same day.

• Brand Name: VARI-LASE PT BRITE TIP
• Type of Device: VARI-LASE PLATINUM BRIGHT TIP LASER FIBER
• 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: 8711554
• MDR Text Key: 148407248
• Report Number: 2134812-2019-00044
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K091551
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/20/2019

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/20/2019
• Initial Date FDA Received: 06/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention