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 10/26/2022

Event Type  malfunction  

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.(b)(4).

Event Description

An angiodynamics territory manager (tm) reported an issue with a nevertouch 65cm kits w/gripper and rfid t.While unpacking, it was found that 2 kits had a "crease" in the laser fiber and sheath.This crease had cause the fibr to fracture and the tre-sheath was bent.There was no patient involvement with the reported issue.

Manufacturer Narrative

Returned for evaluation ((b)(4)) was an unopened evlt kit pouch for lot number 5734575.While reviewing the components, it was noted there was a kink on the tre-sheath (and its shipping tube), the dilator (and its shipping tube) and a crease of the pouch.  in addition, contrary to the complaint description there was no damage to the fiber device.This failure mode does not meet the criteria for a reportable adverse event, however in order to close out the complaint record this medwatch is being submitted.The noted kink of the tre-sheath was 8cm from the tip and the noted kink of the dilator was 14cm from the tip.The customer's reported complaint description of a kit that had kinks in dilator and tre-sheath tubing (and their shipping tubes) was confirmed based on the sample returned for (b)(4) (1319211-2022-00050).The root cause of the kinked tubing is likely damage due pouch and tubing being creased; potentially during transit and/or storage at the customer facility between shipment date of 11-may-2022 and event date of 26-oct-2022.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.Manufacturing personnel 100% visually inspect devices during the packaging process.  this type of tubing kink damage would be noticed prior to shipment.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 ; 5086587805
• MDR Report Key: 15790271
• MDR Text Key: 307912294
• Report Number: 1319211-2022-00051
• 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: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/07/2022

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
• Device Operator: Health Professional
• Device Model Number: 11403002
• Device Catalogue Number: 11403002
• Device Lot Number: 574575
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/26/2022
• Initial Date FDA Received: 11/14/2022
• Supplement Dates Manufacturer Received: 12/02/2022
• Supplement Dates FDA Received: 12/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1