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

Model Number	11403004
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported defective device has yet to be returned to the manufacturer for a device evaluation.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.Reference complaint (b)(4).
Event or Problem Description
As reported: a patient of unknown age and gender presented for an evlt procedure using the never touch system.During the procedure, the fiber stop detached, allowing the laser fiber to advance further into the patient than anticipated.It was reported the fiber had been fired prior to noticing the loose fiber stop, but the patient did not experience any adverse effects due to the loose fiber stop.The device was set aside and a new of the same device was used to successfully complete the procedure.It was reported the disposable device is available for return to the manufacturer for a device evaluation.
Additional Manufacturer Narrative
Returned for evaluation was an 90cm evlt fiber.A visual inspection was performed on the fiber, no noted visual defects along the fiber shaft.The fiber lok could be moved freely along the fiber shaft.Adhesive was present on both side of the fitting.There was no evidence of any force being applied to the sheath lok fitting.The customer's reported complaint description of "fiber lok not welded to the fiber." is confirmed.Since there is no evidence of physical mishandling and there is a full and complete adhesive fillet on both sides of the sheath lok fitting, potentially the bond strength was adversely affected by the surface of the fiber not being cleaned sufficiently.During the manufacturing process, the disposable fiber device receives a 100% inspection and an aql inspection in which the quality of the fiber strip is inspected.Prior to packaging, all components are inspected for damage.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.Labeling review: the instructions for use (ic 393) 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." 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.Reference complaint (b)(4).

• Brand Name: VENACURE NEVERTOUCH FIBER
• Common Device Name: VENACURE ENDOVENOUS LASER TREATMENT FIBER
• Manufacturer (Section D): ANGIODYNAMICS, INC; 603 queensbury avenue; queensbury, ny NY 12804
• MDR Report Key: 9617319
• Report Number: 1319211-2020-00010
• Device Sequence Number: 11432325
• Product Code: GEX
• UDI-Device Identifier: H787114030040
• UDI-Public: H787114030040
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K171921
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2020

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: Health Professional
• Device Model Number: 11403004
• Device Catalogue Number: H787114030040
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2020
• Supplement Date Received by Manufacturer: 01/14/2020
• Initial Report FDA Received Date: 01/22/2020
• Supplement Report FDA Received Date: 02/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1