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

Catalog Number	H787114030130
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/13/2019
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
During an evlt procedure, when the treating physician pulled the laser fiber back through the tre-sheath, the tip of the fiber fractured off the fiber shaft and remained lodged in the tre-sheath.The device was set aside and the procedure was completed with a new of the same device.There was no harm to the patient as the tip remained inside of the tre-sheath.The disposable device has been returned to the manufacturer for a device evaluation.
Additional Manufacturer Narrative
Returned for evaluation was a nevertouch evlt fiber.A visual review of the fiber noted that the gold tip tube had detached from the fiber.The fiber shows that the gold tip was properly crimped to the fiber buffer, there was no noted damage to the fiber tip.The gold tip showed to have dried blood, after the tip was cleaned it showed that there was no noted damage and there was no noted burn marks which is caused by excessive heating.Angiodynamics' manufacturing engineering for this product determined: "after reviewing the fiber sample, it is believed the tip failure was due to the application of excessive force on the gold tube when attempting to withdraw the fiber assembly back through the tre sheath at the completion of a procedure".The customer's reported complaint description was confirmed.The root cause of the separation is due to using excessive force was exerted onto the gold tip when attempting to withdraw it into the tre sheath.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.The instructions for use, 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 radius of 60mm".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 12804
• MDR Report Key: 8474749
• Report Number: 1319211-2019-00028
• Device Sequence Number: 1920507
• Product Code: GEX
• UDI-Device Identifier: H787114030130
• UDI-Public: H787114030130
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K171921
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2019

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 Expiration Date: 06/19/2018
• Device Catalogue Number: H787114030130
• Device Lot Number: 5349147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2019
• Supplement Date Received by Manufacturer: 03/13/2019
• Initial Report FDA Received Date: 04/02/2019
• Supplement Report FDA Received Date: 07/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1