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

Model Number 11403002

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/15/2023

Event Type  malfunction  

Event Description

End user reported that the tip of 65cm nevertouch evlt fiber broke off in the catheter/sheath after being used for patient treatment.This occurred outside of the patient as the procedure had been completed.There was no damage visually observed to the packaging of the device.

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).

Manufacturer Narrative

The customer's reported complaint of the fiber fractured and detached was not confirmed due to no sample being returned.Without receiving a complaint sample, a definitive root cause cannot be determined.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 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 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." 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
• Type of Device: 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 ; 5086587990
• MDR Report Key: 17071826
• MDR Text Key: 317068043
• Report Number: 1319211-2023-00037
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: H787114030020
• UDI-Public: H787114030020
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171921
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/12/2023

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
• Device Operator: Health Professional
• Device Model Number: 11403002
• Device Catalogue Number: 11403002
• Device Lot Number: 5746595
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/18/2023
• Initial Date FDA Received: 06/06/2023
• Supplement Dates Manufacturer Received: 07/11/2023
• Supplement Dates FDA Received: 07/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1