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

Model Number 7147

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/08/2018

Event Type  Injury  

Manufacturer Narrative

A manufacturing record review was unable to be completed as the lot number was unknown.A returned product evaluation was also unable to be completed, as no product was returned to vsi.Based on the account's description and after speaking with the patient, there are several potential causes related to what the broken tip could be and what could have caused the incident.There are several different causes that could be related to the breakage of an introducer sheath.The most likely root cause would be an improper positioning of the fiber related to the sheath.The ifu also precautions that, "use of excessive energy or incorrect positioning of the fiber relative to the sheath has been reported to compromise the integrity of the laser fiber and/or sheath and may result in fragments of a device remaining in the patient or a burn injury." the tip of the fiber is the other possibility of the broken tip.If this were to occur, it would most likely be related to a crack or damage to the fiber.The ifu specifically precautions to "inspect the laser fiber and introducer sheath prior to use for any bends, kinks or breaks." also, the ifu precautions to exercise care in handling of the laser fiber during a procedure to reduce the possibility of accidental breakage, bending or kinking." the tip of the device was described as being white in appearance.Based on this description, it is most probable that the broken piece was the introducer sheath which is also white.The tip of the fiber is still a possibility, but given its metallic appearance it is less likely.With no lot number provided and no product returned, the root cause cannot be confirmed.

Event Description

Ultra sound tech said a piece of the tip of the vl catheter broke off in patients leg.Additional information received: patient had varicose veins burst through the surface of skin twice.Patient went to the er, at which point was referred to a physician who is a vascular surgeon.Patient went in for 1st varicose vein ablation around early (b)(6).At some point between (b)(6), physician office called and told patient that the 1st procedure didn't completely block off the vein.Patient went back in for 2nd varicose vein ablation case on (b)(6).This procedure did block off the remainder of the varicose vein, however, patient received a phone call from the physician's office between (b)(6) where they told the patient that physician wanted him to come back in to explain the situation.Patient found out during (b)(6) appointment, that a piece of the device was left in the vein.Patient said, that they could feel where the piece was, but it didn't get infected or swell up.Patient said unsure when they found out about the piece left in the leg, but it sounded like physician's office were reviewing the ultrasound and that was when they discovered the piece had been left in the leg.Patient described the piece that was removed as a solid white piece about half the length of a toothpick (~ 1 inch).Patient said it was white, not metallic, and looked like it had a hole in the middle - a small black canal that went through it.Physician waited until the vein had healed and then patient went back on (b)(6) to have it removed.They used local numbing and removed the piece, and then they stitched the incision.Over some days, a lump about the size of a half dollar formed over the stitched area, and an 8" x 8" black and blue mark formed around the incision.At some point, patient went to see their primary doctor, who confirmed the 8"x 8" size.Patient went in on (b)(6) and physician confirmed that it was a hematoma.

• Brand Name: VARI-LASE PT BRIGHT TIP
• Type of Device: VARI-LASE PLATINUM BRIGHT TIP LASER FIBER
• 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: 7621607
• MDR Text Key: 111830496
• Report Number: 2134812-2018-00041
• 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,consum
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/22/2018

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: 7147
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/22/2018
• Initial Date FDA Received: 06/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR