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

Catalog Number H787EVLTPVAKUS5

Device Problems Fracture (1260); Device Damaged Prior to Use (2284); Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Event Description

A medical assistant reported an issue with a pvak -- 400 micron perforator and accessory vein ablation kit.It was reported that the kit contained only blue coating at the tip, without an internal, clear fiber.This was discovered while unpacking the device; therefore, there was no patient involvement.

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).

Manufacturer Narrative

The customer's reported complaint description of distal portion of fiber tip was fractured and detached was confirmed based on visual inspection of the returned fiber complaint sample.The distal portion of the fiber tip was broken off and not returned.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 removing the coil wrap from the fiber during the unpacking process.Manufacturing personnel 100% visually inspect devices during the packaging process.This type of fiber fracture/detached damage would be noticed prior to shipment.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 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: 18825296
• MDR Text Key: 337221406
• Report Number: 1319211-2024-00032
• 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: Consumer,Health Professional,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/23/2024

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: 5806941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2024
• Initial Date Manufacturer Received: 02/05/2024
• Initial Date FDA Received: 03/04/2024
• Supplement Dates Manufacturer Received: 04/18/2024
• Supplement Dates FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1