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

Model Number	11403001
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/28/2019
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.Reference complaint (b)(4).
Event or Problem Description
During preparation for the procedure, when the laser fiber was removed from the sterile packaging, it was noted the fiber was bent/fractured.The device was set aside and a new of the same device was used to successfully complete the procedure.There was no harm or injury to the patient due to the event as the device did not come into contact with the patient.It was reported the disposable device is available for return to the manufacturer for a device evaluation.
Additional Manufacturer Narrative
Returned for evaluation was an nevertouch evlt fiber.A visual evaluation of the fiber noted it was fractured 127cm from the gripper.The customer's reported complaint description of the fiber fracturing is confirmed.A review of the returned sample shows the shaft of the fiber shows flaws within the glass core which can impact the resultant fiber strength.A definitive root cause cannot be determined.Per the manufacturing engineer for this product family, "the root cause was most likely due to an inherent flaw in the fiber glass core that failed while the fiber was packaged in a coiled configuration".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.Labeling review: the instructions for use which is supplied to the end user with this catalog number contains the following statement "precaution: 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.Clinical safety and effectiveness data is not available for other fiber tip designs and diameters".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 NY 12804
• MDR Report Key: 9315196
• Report Number: 1319211-2019-00100
• Device Sequence Number: 560434
• Product Code: GEX
• UDI-Device Identifier: H787114030010
• UDI-Public: H787114030010
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K171921
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2020

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: 11403001
• Device Catalogue Number: H787114030010
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2019
• Supplement Date Received by Manufacturer: 10/28/2019
• Initial Report FDA Received Date: 11/13/2019
• Supplement Report FDA Received Date: 02/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1