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

Model Number	11403001
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported defective device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference pr(b)(4).
Event or Problem Description
2nd fiber: an angiodynamics tm reported an end user experienced an issue with a nevertouch laser fiber.The customer reported that they received two laser kits that where defective /damage one was kinked very severely and the other was cut.Both kits were opened for the same patient/procedure.It was reported the procedure was completed with a new of the same device.There was no patient harm or injury due to this event.The reported device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.
Additional Manufacturer Narrative
Returned for evaluation was a nevertouch fiber.As "received", the fiber shaft was a bent 8mm from fiber gripper, a second break was found 118.5cm distal from the break near the molded strain relief.The break near the molded strain relief aligns with the tear in the die card.At the two break points, the buffer is torn / stretched and the glass core appears to have been crushed.There are indentations in the die card where the tear occurred that appear to be the result of the coiled fiber being pressed against the die card with a significant force.The fiber was connected to the tagwrite, it was noted that the fiber has not been fired.The customer's reported complaint description of the fiber fracturing is confirmed.A review of the returned sample shows the fiber was damaged along with damage on the die card, this could occur when handling.As stated in the ifu "avoid damaging the fiber by striking, stressing or excessive bending.Do not coil the fiber tighter than a diameter of 16cm." the reported defect cannot be determined as it appears the damage to this kit most likely resulted from being subjected to some unusual handling conditions after the kit was packaged.A lot history records search for the nevertouch kit revealed no quality related issues or manufacturing deficiencies at the time of manufacture.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, states: "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.Clinical safety and effectiveness data is not available for other fiber tip designs and diameters.Prior to and during use, avoid bending the introducer sheath and dilator as this can cause kinks and 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 FIBER
• Common Device Name: VENACURE ENDOVENOUS LASER TREATMENT FIBER
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 11182946
• Report Number: 1319211-2021-00006
• Device Sequence Number: 14404194
• Product Code: GEX
• UDI-Device Identifier: H787114030010
• UDI-Public: H787114030010
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2021

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: 10/31/2023
• Device Model Number: 11403001
• Device Catalogue Number: 11403001
• Device Lot Number: 5637104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2020
• Supplement Date Received by Manufacturer: 12/28/2020
• Initial Report FDA Received Date: 01/17/2021
• Supplement Report FDA Received Date: 01/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1