MAUDE Adverse Event Report: ANGIODYNAMICS VENACURE NEVERTOUCH FIBER; VENACURE ENDOVENOUS LASER TREATMENT FIBER

Catalog Number	11403002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Undesired Nerve Stimulation (1980); Numbness (2415)
Date of Event	11/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
An end user reported an issue with a nevertouch 65cm kit w/ gripper and rfid t.During a procedure, the fiber would work and then shut off.This cycle was performed twice; however, another same device was ultimately used to complete the procedure.Five days following the procedure, patient reported feeling coldness, numbness and a "buzz" in her leg.The nurse believes this may be nerve damage and will take some time to resolve; however, the patient does not require any type of medical intervention for these symptoms.
Additional Manufacturer Narrative
It was reported that the device is not available to be returned to the manufacturer for evaluation.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).
Additional Manufacturer Narrative
He customers reported complaint of "the fiber was defective" cannot be confirmed due to the complaint sample was not returned.Without receiving the complaint sample for evaluation a definitive root cause for this event cannot be determined.The reported patient issue of cold/numbness sensation and "buzz" in her leg cannot be confirmed due to the patient centric nature of these issues.The nurse at the customer facility stated, "this could possibly be nerve damage and could take some time to resolve".Paresthesia due to thermal damage of adjacent sensory nerves is an anticipated potential complication that is cautioned in the instructions for use.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; i.E.No ncr associated with reported failure mode.Labeling review: instructions for use (16650393-01) are provided with the evlt fiber device and include the following statements: potential complications: the potential complications include but are not limited to the following: vessel perforation, thrombosis, pulmonary embolism, phlebitis, hematoma, infection, skin pigmentation alteration, neovascularization, paresthesia due to thermal damage of adjacent sensory nerves, anesthetic tumescence, non-target irradiation, hemorrhage, necrosis, skin burns and pain.Warnings: - treatment of a vein located close to the skin surface may result in skin burn.- paresthesia may occur from thermal damage to adjacent sensory nerves.The user manual (man/31/0075 us), states "the venacure 1470 laser will only permit a procedure to be carried out if an angiodynamics frs fiber is used.An incompatible fiber will be shown on the screen as invalid fiber." the following error messages are associated with the fiber recognition system "fiber uses expired - replace the fiber with a fiber that has not already been use and fiber sterility expired - angiodynamics fibers are programmed at manufacture with a sterility expiration date.This message is displayed when the expiry date is before the date in the laser's internal clock.Replace the fiber with one having a valid sterility expiration date." furthermore, "invalid fiber is displayed even with a new unused frs system fiber (1) disconnect and then reconnect the fiber to the venacure 1470 laser.This will cause the unit to try and read the fiber's data again.(2) switch the venacure 1470 laser off and on at the power inlet.3) ensure that the venacure 1470 laser is at least 2 meters away from any other electrical or electronic equipment that might interfere with the frs system, such as computers or other electronic or medical equipment".In the case of an emergency override it is stated, "in certain circumstances, such as a technical problem or if the emergency stop button is pressed, the fiber in use may become invalid before the completion of the treatment.If this situation should occur, the emergency override may be activated to allow treatment to continue.This option is only available immediately after the fault has been cleared and will not work if an attempt is made to use an expired or otherwise invalid fiber at any other time." 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 pr(b)(4).
Additional Manufacturer Narrative
The customer's reported complaint of "the fiber was defective" cannot be confirmed due to the complaint sample not being returned.Without receiving the complaint sample for evaluation, a definitive root cause for this event cannot be determined.The reported patient issue of cold/numbness sensation and "buzz" in her leg cannot be confirmed due to the patient centric nature of these issues.The nurse at the customer facility stated, "this could possibly be nerve damage and could take some time to resolve".Paresthesia due to thermal damage of adjacent sensory nerves is an anticipated potential complication that is cautioned in the instructions for use.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; i.E.No ncr associated with reported failure mode.Labeling review: instructions for use ((b)(6)) are provided with the evlt fiber device and include the following statements: potential complications: the potential complications include but are not limited to the following: vessel perforation, thrombosis, pulmonary embolism, phlebitis, hematoma, infection, skin pigmentation alteration, neovascularization, paresthesia due to thermal damage of adjacent sensory nerves, anesthetic tumescence, non-target irradiation, hemorrhage, necrosis, skin burns and pain.Warnings: treatment of a vein located close to the skin surface may result in skin burn.Paresthesia may occur from thermal damage to adjacent sensory nerves.The user manual (man/31/0075 us), states "the venacure 1470 laser will only permit a procedure to be carried out if an angiodynamics frs fiber is used.An incompatible fiber will be shown on the screen as invalid fiber." the following error messages are associated with the fiber recognition system "fiber uses expired - replace the fiber with a fiber that has not already been use and fiber sterility expired - angiodynamics fibers are programmed at manufacture with a sterility expiration date.This message is displayed when the expiry date is before the date in the laser's internal clock.Replace the fiber with one having a valid sterility expiration date." furthermore, "invalid fiber is displayed even with a new unused frs system fiber (1) disconnect and then reconnect the fiber to the venacure 1470 laser.This will cause the unit to try and read the fiber's data again.(2) switch the venacure 1470 laser off and on at the power inlet.3) ensure that the venacure 1470 laser is at least 2 meters away from any other electrical or electronic equipment that might interfere with the frs system, such as computers or other electronic or medical equipment".In the case of an emergency override it is stated, "in certain circumstances, such as a technical problem or if the emergency stop button is pressed, the fiber in use may become invalid before the completion of the treatment.If this situation should occur, the emergency override may be activated to allow treatment to continue.This option is only available immediately after the fault has been cleared and will not work if an attempt is made to use an expired or otherwise invalid fiber at any other time." 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 NEVERTOUCH FIBER
• Common Device Name: VENACURE ENDOVENOUS LASER TREATMENT FIBER
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer (Section G): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587990
• MDR Report Key: 18290650
• Report Number: 1319211-2023-00090
• Device Sequence Number: 20544785
• Product Code: GEX
• UDI-Device Identifier: H787114030020
• UDI-Public: H787114030020
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K171921
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/09/2024

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 Expiration Date: 04/30/2026
• Device Catalogue Number: 11403002
• Device Lot Number: 5779499
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2023
• Supplement Date Received by Manufacturer: 01/23/2024; 01/23/2024
• Initial Report FDA Received Date: 12/08/2023
• Supplement Report FDA Received Date: 02/09/2024; 02/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Weight: 179 KG