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

Catalog Number	H787114030010
Medical Device Problem Code	Continuous Firing (1123)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was indicated the disposable device is available to return to the manufacturer for a device evaluation.The reported defective device has yet to be returned to the manufacturer.The firm is attempting to obtain the device.An investigation into the root cause for product problem is currently in progress.The results of the device evaluation will be sent via a follow up medwatch.(b)(4).
Event or Problem Description
As reported to angiodynamics on (b)(6) 2018: it was reported that then the fiber had been withdrawn from the patient, the fiber continued to fire even after the foot pedal was disengaged.The treating physician tapped the foot pedal to ensure the switch was not stuck.The fiber continued to fire for approximately 4 seconds before the laser unit displayed "fiber invalid." the fiber was set aside and a new of the same was used to complete the procedure.There was no patient harm as the event occurred outside of the patient.It was reported the disposable device is available for return to the manufacturer for a device evaluation.
Additional Manufacturer Narrative
Received for evaluation was a 45cm fiber.A visual inspection noted no appearance of defect or damage.During functional testing of the returned fiber, the test unit displayed "invalid fiber".The fiber was then connected to a precision 980 laser.The aiming intensity was set at 3 the beam was bright and rounded.When the laser pedal was disengaged the fiber stopped firing immediately.The customer's reported complaint description of "the fiber continued to fire after pedal was disengaged" cannot be confirmed as the fiber stopped firing as soon as the pedal was disengaged.During the evaluation of the fiber, the complaint of an invalid fiber message was confirmed.Although a root cause for the fiber continuing to fire could not be definitively determined, a possible contributing factor could be an issue with the foot pedal on the laser.The contacts in the foot pedal must engage/disengage within a predetermined timeframe when working properly.The most likely root cause of the "invalid fiber" error message could be related to the laser as well, possibly the faulty foot pedal as described above.The tagwrite program read that there was a bad "anti-copy mode" which can happen during the manufacturing process or a bad read from the laser.This most likely did not happen during the manufacturing programming process since the report did not show a failure when it was printed out.During the manufacturing process each fiber receives two 100% inspections to ensure that they are programed properly.A review of the angiodynamics' 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.The user manual, 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 trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.(b)(4).

• Brand Name: VENACURE NEVERTOUCH FIBER
• Common Device Name: ENDOVENOUS LASER TREATMENT FIBER
• Manufacturer (Section D): ANGIODYNAMICS, INC; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 7334820
• Report Number: 1319211-2018-00029
• Device Sequence Number: 287111
• Product Code: GEX
• UDI-Device Identifier: H787114030010
• UDI-Public: H787114030010
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Hospital Service Technician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2018

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: 11/30/2020
• Device Catalogue Number: H787114030010
• Device Lot Number: 5272289
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2018
• Supplement Date Received by Manufacturer: 03/06/2018
• Initial Report FDA Received Date: 03/13/2018
• Supplement Report FDA Received Date: 06/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1