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

Model Number	11403005
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported defective device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.The results of the device evaluation will be sent via a follow up medwatch.Reference complaint (b)(4).
Event or Problem Description
A patient of unknown age and gender presented for an evlt procedure using a nevertouch fiber.The treating physician successfully treated the patient's first leg, and withdrew the fiber in order to treat the second leg.While cleaning the laser fiber prior to insertion into the second leg, the gold tip of the fiber detached.The device was set aside and a new of the same device was used to complete the procedure.There was no harm or injury to the patient due to this event.The disposable device has been returned to the manufacturer for a device evaluation.
Additional Manufacturer Narrative
Returned for evaluation was an evlt fiber and gold tip.A visual review of the fiber noted that the gold tip tube had detached from the fiber.The customer's reported complaint description was confirmed; the tip was observed to be detached from the fiber.The manufacturing engineer for this product evaluated the return sample and confirmed the fiber was manufactured correctly as evidenced by proper crimp marks on the tube tip and fiber shaft were present.A potential root cause of the separation could be due to adverse handling of the fiber assembly at some point or possibly due to an inherent flaw in the fiber glass core that could not withstand the thermal changes that can occur in the tip area during a procedure.A lot history records search for the nevertouch kit revealed no quality related issues or manufacturing deficiencies at the time of manufacture.During the manufacturing process, the disposable fiber device receives a 100% inspection and an aql inspection in which the quality of the fiber strip is inspected.Labeling review: the instructions for use (ic 393) which is supplied to the end user with this 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 diameter of 20cm" and "pull the sheath back and lock it to the sheath-lok fitting." 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
• Common Device Name: VENACURE ENDOVENOUS LASER TREATMENT FIBER
• Manufacturer (Section D): ANGIODYNAMICS, INC; 603 queensbury avenue; queensbury, ny
• MDR Report Key: 9805818
• Report Number: 1319211-2020-00015
• Device Sequence Number: 14156980
• Product Code: GEX
• UDI-Device Identifier: H787114030050
• UDI-Public: H787114030050
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K171921
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2020

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: Health Professional
• Device Model Number: 11403005
• Device Catalogue Number: H787114030050
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2020
• Supplement Date Received by Manufacturer: 02/14/2020
• Initial Report FDA Received Date: 03/09/2020
• Supplement Report FDA Received Date: 03/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1