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

Catalog Number	H787114030050
Medical Device Problem Codes	Unsealed Device Packaging (1444); Device Packaging Compromised (2916)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Date of Event	01/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported defective device has yet to be returned to the manufacturer for a device evaluation.The firm is attempting to obtain the device.An investigation into the root cause for product problem is currently in progress.The results of the device evaluation will be sent via a follow up medwatch.(b)(4) device not returned to date.
Event or Problem Description
As reported (b)(6) 2017, when the reporting medical facility received the product, one of the packages within the shipment had a tear in the packaging, compromising the sterility of the product contained within.It was reported the disposable device is available for return to the manufacturer for evaluation.
Additional Manufacturer Narrative
This complaint was originally assessed as meeting the criteria of a reportable event.Based on new information presented for this complaint (sample evaluation), it has been reassessed as no longer meeting the criteria of a reportable event.This complaint did not involve a serious injury, serious illness or serious adverse event.If this malfunction were to reoccur it would not cause or contribute to a death or serious injury.Mdr/ vigilance reporting not required.Returned for evaluation was 45cm nevertouch kit.A visual review of the kit noted that the pouch has been opened along the seals.The dilator has been removed.The edges of the pouch along the open seals, have been taped closed.The customer's reported complaint description of an opened pouch is confirmed.A lot history records search revealed no quality related issues or manufacturing deficiencies at the time of packaging.During the packaging process, the pouch receives three 100% visual inspection for damage.As the dilator has been removed, the most likely root cause is that at the complainant facility, the pouch was opened and the dilator removed to be used in another procedure, leaving the remaining components in the pouch.Though this cannot be definitively determined, it is highly unlikely that the kit was shipped to the user opened and with a component removed.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.(b)(4).

• Brand Name: VENCURE NEVERTOUCH
• Common Device Name: ENDOVENOUS LASER TREATMENT FIBER
• Manufacturer (Section D): ANGIODYNAMICS, INC.; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 6299636
• Report Number: 1319211-2017-00011
• Device Sequence Number: 822339
• Product Code: GEX
• UDI-Device Identifier: H787114030050
• UDI-Public: H787114030050
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K031233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2016

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
• Operator of Device: No Information
• Device Catalogue Number: H787114030050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/06/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/03/2017
• Supplement Report FDA Received Date: 04/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1