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

Model Number	11403012
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	11/02/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Event 1 of 2: a nurse reported a patient issue that occurred during two separate evlt procedures.The patient experienced what is believed to be an allergic reaction during the last 2 sessions, resulting in swollen lips and tightening of the throat.Treatment was paused until the patient improved and then resumed once the patient's reaction subsided.It was reported it took approximately 15 to 20 minutes for the reactions to subside.The treatments were then completed successfully with no further allergic reactions.In both events, the patient was not treated with any medication or intervention for the allergic reaction.The patient will be seeing an allergist.It was reported the patient does have an allergy to an undisclosed medication.
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).Reference reports: (b)(4) 1st event: 1319211-2022-00003.(b)(4) 2nd event 1319211-2022-00004.
Additional Manufacturer Narrative
As the reported device was not returned, angiodynamics is unable to perform a device evaluation.The customer's reported complaint description of patient allergic reaction cannot be confirmed given the patient centric nature of this event.There was no reported fiber malfunction during the procedure, just patient allergic reaction that cleared on its own after 15-20 minutes.A definitive root cause for the patient reaction during the procedure could not be determined.A potential contributing factor to patient allergic reaction is the tumescent that is typically injected during vein ablations.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: the instructions for use (ic 393) which is supplied to the end user with this catalog number states, "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, dehp exposure, skin burns and pain".The user manual (man/31/0075), which is supplied to the user with this unit contains the following warnings and statements: "clinical warnings: as with any conventional surgical operations, adverse reactions may occur following treatment", "irradiation of any substance or material other than the target treatment of varicose veins and varicosities may result in a laser burn", "contraindications: the venacure 1470 laser is contraindicated for: · patients with thrombus in the vein segment to be treated · patients with an aneurysmal section in the vein segment to be treated · patients with peripheral artery disease as determined by an ankle-brachial", and, "potential complication: the potential for complications exists, including: · 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· dehp exposure· skin burns and pain(this is not an exhaustive list.)".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).Reference reports: (b)(4) 1st event: 1319211-2022-00003.(b)(4) 2nd event 1319211-2022-00004.
Additional Manufacturer Narrative
Reference (b)(4).Reference reports: (b)(4) 1st event: 1319211-2022-00003; (b)(4) 2nd event 1319211-2022-00004.

• 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 ; 5086587805
• MDR Report Key: 13385462
• Report Number: 1319211-2022-00003
• Device Sequence Number: 11995830
• Product Code: GEX
• UDI-Device Identifier: H787114030120
• UDI-Public: H787114030120
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/09/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2024
• Device Model Number: 11403012
• Device Catalogue Number: 11403012
• Device Lot Number: 5693621
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2022
• Supplement Date Received by Manufacturer: 01/31/2022; 03/07/2022
• Initial Report FDA Received Date: 01/28/2022
• Supplement Report FDA Received Date: 02/08/2022; 03/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2021
• 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: 60 YR
• Patient Sex: Female