MAUDE Adverse Event Report: ANGIODYNAMICS, INC. VENACURE EVLT; VENACURE 400 MICRON PERFORATOR AND ACCESSORY VEIN ABLATION KIT

Catalog Number H787EVLTPVAKUS5

Device Problem Fracture (1260)

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

Event Date 02/12/2024

Event Type  malfunction  

Manufacturer Narrative

The reported defective device has been received by 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 Description

A physician reported an issue with a pvak -- 400 micron perforator and accessory vein ablation kit.During introduction, the physician noticed the fiber had a crack in it, approximately 10-15 cm from the tip, and a red light was being emitted from the crack.The physician began to look at the partial fracture more closely and, in the process, completely fractured the fiber.This fiber never went inside the patient.The following procedure was completed with another same device and the patient did not experience any adverse effects, harm, or require medical intervention as a result of this incident.

Manufacturer Narrative

The customer's reported complaint description of the fiber was fractured was confirmed based on visual inspection of the returned fiber complaint sample.The likely root cause of the fiber fracture is handling damage but when and how this occurred cannot be definitively determined.The fiber tip is packaged such that the tip of the fiber is located under the coil wrap.A potential contributing factor for the fiber fracture is the coil wrap and/or the process of end user attempting to remove the coil wrap from the fiber during the unpacking process.Manufacturing personnel 100% visually inspect devices during the packaging process.This type of fiber kink/detached damage would be noticed prior to shipment.A device history record review of the indicated packaging/assembly lots revealed no quality related issues or manufacturing deficiencies at the time of manufacture.Labeling review: the directions for use (16601420-01) which is supplied to the end user with the reported catalog number contains the following statement "prior to and during use, avoid damaging the fiber by striking, stressing or excessive bending.Do not coil the fiber tighter than a radius of 60mm".The user manual (man/31/0075 us), 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 pr(b)(4).

• Brand Name: VENACURE EVLT
• Type of Device: VENACURE 400 MICRON PERFORATOR AND ACCESSORY VEIN ABLATION KIT
• Manufacturer (Section D): ANGIODYNAMICS, INC.; 603 queensbury avenue; queensbury NY 12804
• Manufacturer (Section G): ANGIODYNAMICS, INC.; 603 queensbury avenue; queensbury NY 12804
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587990
• MDR Report Key: 18866086
• MDR Text Key: 337221624
• Report Number: 1319211-2024-00033
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: H787EVLTPVAKUS5
• UDI-Public: H787EVLTPVAKUS5
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/23/2024

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 Catalogue Number: H787EVLTPVAKUS5
• Device Lot Number: 5808704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2024
• Initial Date FDA Received: 03/08/2024
• Supplement Dates Manufacturer Received: 03/18/2024
• Supplement Dates FDA Received: 03/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/27/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1