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

Catalog Number	11403101
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported device has yet to be returned to the manufacturer for a device evaluation.An investigation into the root cause for product problem is currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).
Event or Problem Description
Ansm (france national competent authority) notified angiodynamics of an event that occurred with a laser fiber from a never touch direct procedure kit.The end user had reported that during a procedure, the tip of the fiber became loose.The fiber was exchanged for a new of the same device to complete the procedure.There was no report of the patient experiencing any adverse effects, harm, or require medical intervention as a result of this incident.
Additional Manufacturer Narrative
As the reported device was not returned, angiodynamics is unable to perform a device evaluation.The customer's reported complaint of the fiber tip was loose could not be confirmed; no fiber sample was returned.Without receiving the complaint sample for evaluation a root cause for this event cannot be determined.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.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.Labeling review: the instructions for use which is supplied to the end user with this catalog number contains the following statement "avoid damaging the fiber by striking, stressing or excessive bending.Do not coil the fiber tighter than a diameter of 16cm." the user manual, which is supplied to the end user with this unit, states "before using a fiber, check it carefully for any signs of damage during storage or transit.Protective caps should be in place over sma connectors.Do not use if there is any sign of damage." 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).
Event or Problem Description
Additional information provided reported that the gold tip of the fiber fully detached outside the patient.
Additional Manufacturer Narrative
Reference (b)(4).
Additional Manufacturer Narrative
Returned for evaluation was an evlt nevertouch direct fiber and detached gold tip.It appeared that a fracture in the fiber glass core allowed laser energy to be diverted from the fiber glass core and compromised the bonds designed to hold the gold tip tube in place.Most likely the gold tip tube / quartz ferrule bond initially failed and then subsequently the crimp / adhesive bond between the gold tip tube and buffer was compromised which allowed the gold tip tube to move slightly during the initial procedure.Between the fractured fiber glass core and compromised tip tube bond, handling of the tip tube after the initial procedure was sufficient for complete separation of the gold tip tube / quartz ferrule to occur.The customer's reported complaint of the gold tip detached was confirmed.The most likely root cause for the tip detachment was handling of the tip tube after the initial procedure.Although the complaint description was confirmed, a definitive root cause could not be determined.It is possibly due to the fracture of the fiber glass core that compromised the bonds holding gold tip in place, or the result of an impact force against the tip area of the fiber assembly.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.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.Labeling review: the instructions for use which is supplied to the end user with this catalog number contains the following statement "avoid damaging the fiber by striking, stressing or excessive bending.Do not coil the fiber tighter than a diameter of 16cm." the user manual, which is supplied to the end user with this unit, states "before using a fiber, check it carefully for any signs of damage during storage or transit.Protective caps should be in place over sma connectors.Do not use if there is any sign of damage." 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 DIRECT PROCEDURE KIT
• 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: 14315005
• Report Number: 1319211-2022-00020
• Device Sequence Number: 5000628
• Product Code: GEX
• UDI-Device Identifier: H787114031015
• UDI-Public: H787114031015
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/29/2022

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 Expiration Date: 10/31/2024
• Device Catalogue Number: 11403101
• Device Lot Number: 5705687
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2022
• Supplement Date Received by Manufacturer: 05/13/2022; 06/08/2022; 06/28/2022
• Initial Report FDA Received Date: 05/07/2022
• Supplement Report FDA Received Date: 05/20/2022; 06/09/2022; 06/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2021
• 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
• Patient Age: 18 YR
• Patient Sex: Male
• Patient Weight: 77 KG