MAUDE Adverse Event Report: ANGIODYNAMICS, INC. VENACURE EVLT; POWERED LASER SURGICAL INSTRUMENT

Catalog Number EVLT/25-OPS

Device Problem Fracture (1260)

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

Event Date 03/08/2024

Event Type  malfunction  

Manufacturer Narrative

The reported device has not yet been returned to the manufacturer, despite multiple attempts to obtain the sample.An investigation into the root cause for event is currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).

Event Description

An ultrasound technologist reported the following issue with an evlt kit with spotlight ops sheath 25cm: "while dr.(b)(6) was performing an ssv evlt, the 25 cm evlt laser kit that was opened for the procedure could not be used due to a laser fiber that fractured completely in half right after dr.(b)(6) got it correctly positioned in the ssv.The laser fiber was initially locked into place within the catheter, but before we started to inject the tumescence, the laser fiber appeared to pop out of the catheter.Dr.(b)(6) commented that this was weird as he thought that it was locked into place.When he went to re-insert the laser fiber, he noticed that he couldn't pass the laser fiber through the catheter anymore.After trying for a few minutes, he used a scalpel to cut the lock end of the catheter off to see if he could figure out what was happening.It was after he cut the catheter that dr.(b)(6) realized that the laser fiber had cracked completely off inside the catheter.We removed the broken piece and put the broken fiber back into the original packaging before opening a new evlt kit to finish the laser ablation procedure." the patient did not experience any adverse effects, harm, or require medical intervention as a result of this incident.

Manufacturer Narrative

The customer's reported complaint description of fiber fractured confirmed based on visual inspection of the returned fiber complaint sample.The returned fiber was noted to be "fractured" in two places.The od of the fiber was confirmed to meet specification near the fracture locations.The likely root cause of the fiber fracture is handling damage but when and how this occurred cannot be definitively determined.The fiber tip is packaged such that the tip of the fiber is located under the coil wrap.Manufacturing personnel 100% visually inspect devices during the packaging process.This type of fiber kink/detached damage would be noticed prior to shipment.A review of the device history records was performed for the indicated lots for any deviations related to the reported failure mode of the complaint.The review confirms that the lots met all material, assembly and performance specifications.Labeling review: the directions for use (16601410-01) which is supplied to the end user with this catalog number contains the following statement "prior to and during use, avoid damaging the fiber by striking, stressing or excessive bending.Do not coil the fiber tighter than a radius of 60mm" a review of the angiodynamics complaint system noted no adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Reference (b)(4).

• Brand Name: VENACURE EVLT
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): ANGIODYNAMICS, INC.; 603 queensbury avenue; queensbury NY 12804
• Manufacturer (Section G): ANGIODYNAMICS, INC.; 603 queensbury avenue; queensbury NY 12804
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587990
• MDR Report Key: 19038796
• MDR Text Key: 339335567
• Report Number: 1319211-2024-00047
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: H787EVLT25OPS0
• UDI-Public: H787EVLT25OPS0
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EVLT/25-OPS
• Device Lot Number: 5793550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/19/2024
• Initial Date FDA Received: 04/03/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 173 KG