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

Catalog Number	11403002
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported device is not available to be returned to the manufacturer for evaluation.An investigation into the root cause for this event is currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).
Event or Problem Description
A distributor reported a customer complaint against a nevertouch 65cm kit w/gripper and rfid t.During a procedure, when the surgeon removed the laser fiber from the patient's vein, the tip was no longer attached.The sonographer performed an ultrasound of the distal thigh great saphenous vein and identified the laser tip still located within the vessel.Ultimately, the vascular surgeon performed a surgical incision to remove the tip.
Additional Manufacturer Narrative
The customer's reported complaint description of tip detached from fiber was confirmed via the photo that was provided by the customer, although the complaint sample was not returned.Without receiving the complaint sample for evaluation a definitive root cause cannot be determined.Potential contributing factor for this type of tip detachment failure mode is handling damage during use, i.E.After first ablation, pulling fiber back through the tre-sheath tip such that dried blood on gold tip makes od larger and prevents smooth withdrawal.Excess force used during withdrawal that detaches gold tip from the fiber shaft (this occurs outside of the body).Evaluation of the companion samples returned showed no manufacturing non-conformances and the gold tips were securely attached to the fiber shaft.A device history records search for the packaging/assembly lots revealed no quality related issues or manufacturing deficiencies at the time of manufacture.Labeling review: the instructions for use (16900393-01) 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 diameter of 20cm" and "pull the sheath back and lock it to the sheath-lok fitting." the user manual (man/31/0075 us), which is supplied to the end user with this unit, states "before using a fiber, check it carefully for any signs of damage during storage or transit.Protective caps should be in place over sma connectors.Do not use if there is any sign of damage." 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
• Common Device Name: 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: 20038188
• Report Number: 1319211-2024-00063
• Device Sequence Number: 14221846
• Product Code: GEX
• UDI-Device Identifier: H787114030020
• UDI-Public: H787114030020
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K231945
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 11403002
• Device Lot Number: 5818241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2024
• Supplement Date Received by Manufacturer: 10/07/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 10/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown