MAUDE Adverse Event Report: ANGIODYNAMICS, INC. ANGIODYNAMICS ENDOVENOUS LASER FIBER; POWERED LASER SURGICAL INSTRUMENT

Lot Number 5767673

Device Problems Unintended System Motion (1430); Material Protrusion/Extrusion (2979); Protective Measures Problem (3015)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/23/2023

Event Type  malfunction  

Event Description

There was a laser malfunction during the laser procedure for varicose veins which was caught during the procedure.The safety hub on the endovenous laser fiber was mobile instead of fixed, allowing the laser fiber to extend from catheter farther than it should have.Bedside ultrasound was done and no immediate harm was noted to patient, however, she is being sent for serial imaging.Patient was made aware of this situation and was documented.Patient voiced understanding.

• Brand Name: ANGIODYNAMICS ENDOVENOUS LASER FIBER
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): ANGIODYNAMICS, INC.
• MDR Report Key: 17070669
• MDR Text Key: 316672741
• Report Number: MW5118164
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 5767673
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White