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

Catalog Number	H787114030010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Reaction (2414); Patient Problem/Medical Problem (2688)
Date of Event	11/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the disposable device was discarded by the user and is not available to be returned to the manufacturer for evaluation.The results of the device evalaution will be sent via a follow up medwatch.(b)(4).
Event or Problem Description
As reported to angiodynamics on november 29, 2017: it was reported that an 80+ year old female was scheduled for a vein ablation procedure.During the ablation, 1.5l of tumescent anesthesia was used.The procedure was successfully completed with no report of device malfunction or patient complication.After the ablation, the patient was non-responsive and had to physically be awakened.After being awakened, the patient showed signs that were concerning to the staff (sluggish, vomiting, dry heaving, confusion).Staff monitored patient for several hours and then patient went by ambulance to the er.It was reported the disposable device used during the procedure is not available for return to the manufacturer for a device evaluation as it was disposed of by the user.
Additional Manufacturer Narrative
This medwatch is not to report a device malfunction, but to report an adverse patient effect.There was no report of a device malfunction.As the reported defective device was not returned, angiodynamics is unable to perform a device evaluation.Without a device evaluation, angiodynamics is unable to determine a root cause for the reported complaint description.The customer's reported complaint description cannot be confirmed.Without receiving product for evaluation, we are unable to definitively determine a root cause for this incident.A review of the device history records was performed for the reported packaging and component lots for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly, and performance specifications.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: ENDOVENOUS LASER TREATMENT FIBER
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 7133262
• Report Number: 1319211-2017-00134
• Device Sequence Number: 19105365
• Product Code: GEX
• UDI-Device Identifier: H787114030010
• UDI-Public: H787114030010
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K162914
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2018

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
• Operator of Device: Physician
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: H787114030010
• Device Lot Number: 5218240
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2017
• Supplement Date Received by Manufacturer: 11/29/2017
• Initial Report FDA Received Date: 12/20/2017
• Supplement Report FDA Received Date: 03/26/2018
• 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: Hospitalization
• Patient Age: 80 YR