MAUDE Adverse Event Report: ANGIODYNAMICS, INC. VENACURE EVLT; NEVERTOUCH FRS 65CM PROCEDURE KIT

Catalog Number H787114030020

Device Problem Fracture (1260)

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

Event Date 11/01/2023

Event Type  malfunction  

Manufacturer Narrative

The customer's reported complaint description "the account has received 3 broken nevertouch items" could not be confirmed as no product was returned and no pictures provided.Customer did not provide a clear description of what was broken, however, given that this product is an evlt fiber kit the failure mode in question was assigned to be "fiber found to be fractured in the packaging." without receiving a sample, a definitive root cause cannot be determined.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 instructions for use (16900393-01) which is supplied to the end user with this catalog number states."do not use if sterile barrier is damaged.If damage is found, call your sales representative.Inspect prior to use to verify that no damage has occurred during shipping." 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), device 1 of 3, 1319211-2024-00034.Reference (b)(4), device 2 of 3.Reference (b)(4), device 3 of 3, 1319211-2024-00036.

Event Description

An end user reported that the account has received 3 broken nevertouch frs 65cm procedure kits.There was no report of patient involvement, by the end user, as the issue was discovered while unpacking the devices.No further details were able to be provided.Device 2 of 3.

Manufacturer Narrative

Returned for evaluation was an unopened companion sample of the same reported lot number.The sample had no signs of damage/defect, to any component of the device; therefore, no additional investigation actions were warranted.Reference (b)(4).

• Brand Name: VENACURE EVLT
• Type of Device: NEVERTOUCH FRS 65CM PROCEDURE 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: 18882739
• MDR Text Key: 337860558
• Report Number: 1319211-2024-00035
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K231945
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/27/2024

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: H787114030020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/16/2024
• Initial Date FDA Received: 03/11/2024
• Supplement Dates Manufacturer Received: 03/18/2024
• Supplement Dates FDA Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1