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	01/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
An end user reported an issue with a nevertouch 45cm kit.While opening the kit for a procedure, the doctor noted that the laser fiber was kinked.The procedure was completed with another kit.The patient did not experience any adverse effects, harm, or require medical intervention as a result of this incident.
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).
Additional Manufacturer Narrative
Reference (b)(4).
Event or Problem Description
Additional information provided reported that the product was stored hanging on a rack.There was no appearnce of damage to the product packaging.
Additional Manufacturer Narrative
The reported complaint event description of fiber kinked (out of the package) was assessed as meeting the requirements for mdr reportability, however, the dilator component was returned and confirmed to be kinked.The incorrect reporting was confirmed in a good faith effort to the end user.The complaint event is not deemed to be a reportable event for a kinked dilator.This report is being submitted in order to close out the complaint file.Returned for evaluation was a dilator, there was no fiber assembly returned for evaluation.The returned dilator was noted to have a kink at 39.8cm from hub.The customer's reported complaint description of the dilator tubing was kinked/bent was confirmed upon evaluation of the returned sample.The kink in the dilator tubing is consistent with handling damage to the device, however, when this occurred cannot be definitively determined.A device 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.The dilator and the tre-sheath are packaged in shipping tubes to prevent 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
• Manufacturer (Section G): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587805
• MDR Report Key: 13549904
• Report Number: 1319211-2022-00010
• Device Sequence Number: 5186498
• Product Code: GEX
• UDI-Device Identifier: H787114030010
• UDI-Public: H787114030010
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/09/2022

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: 08/31/2024
• Device Model Number: 11403001
• Device Catalogue Number: 11403001
• Device Lot Number: 5695771
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2022
• Supplement Date Received by Manufacturer: 02/23/2022; 03/07/2022
• Initial Report FDA Received Date: 02/17/2022
• Supplement Report FDA Received Date: 03/02/2022; 03/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2021
• 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: 69 YR
• Patient Sex: Male