MAUDE Adverse Event Report: ANGIODYNAMICS, INC VENACURE NEVERTOUCH FIBER; VENACURE ENDOVENOUS LASER TREATMENT FIBER

Catalog Number NOT REPORTED

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that the disposable device was discarded by the user and is not available to be returned to the manufacturer for evaluation.The results of the device evaluation will be sent via a follow up medwatch.Reference complaint # (b)(4).

Event Description

As reported : the account reported they had received three nevertouch 65cm convenience kit packages that were opened.Therefore the product was no longer sterile.The opened packages were noticed while prepping for an evlt procedure in a sterile setting.One of the packages appeared to be sealed, but was not.The other two were opened about 2 inches or smaller.There was no air in the package.Also, no photos can be provided.This was noticed during the procedure.They first opened the microaccess kit, waited for access, then saw that fiber package was not sealed properly.All three pouches were not noticed at the same time.It was only noticed right before the fiber was needed for the procedure.They currently hang the pouches.It was reported the packages are not available for return to the manufacturer for a an evaluation as it was disposed of by the user.

Manufacturer Narrative

As the reported defective device was not returned, angiodynamics is unable to perform a device evaluation.The customer's reported complaint of "packaging was not sealed" was not confirmed; no product was returned and photo's weren't provided.Without receiving product for evaluation we cannot determine the root cause for the sterility breach.A lot history records search, obtained via ship history, revealed no quality related issues or manufacturing deficiencies at the time of manufacture.A potential root cause is handling damage after leaving the angiodynamics facility.A review of the angiodynamics' device history records was performed for the reported packaging and component lots for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly, and performance specifications.A review of the angiodynamics complaint system noted no trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Reference complaint (b)(4).

• Brand Name: VENACURE NEVERTOUCH FIBER
• Type of Device: VENACURE ENDOVENOUS LASER TREATMENT FIBER
• Manufacturer (Section D): ANGIODYNAMICS, INC; 603 queensbury avenue; queensbury, ny NY 12804
• MDR Report Key: 9535479
• MDR Text Key: 175931844
• Report Number: 1319211-2019-00123
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• PMA/PMN Number: K171921
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 02/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NOT REPORTED
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1