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

Model Number 11403001

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/14/2023

Event Type  malfunction  

Manufacturer Narrative

The reported device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).

Event Description

During preparation , and prior to placing the nevertouch 45cm fiber into the patient, it was noted that there was a hole/crack in the laser catheter where the red light shone through.The fiber was placed aside and a new of the same kit was opened to complete the procedure.The patient did not experience any adverse effects, harm, or require medical intervention because of this incident.

Manufacturer Narrative

Returned for evaluation was one (1) fiber which was noted to be fractured.The site of the fracture was examined under magnification, revealing a somewhat jagged break in the fiber core and distortion of the buffer layer on each side of the point of the break, indicating stress was exerted on the fiber causing it to fracture.The source of the stress cannot be conclusively isolated, but the rfid tag data indicated that the fiber was not used.This eliminates laser energy as a likely contributor to the break.The customer's reported complaint of fiber shaft was observed to be fractured during preparation is confirmed.Returned fiber sample has a fracture in the fiber shaft and tag write data shows fiber had not been used.A definitive root cause for the fiber fracture could not be determined, however, potential contributing factors include some level of stress was exerted on the fiber (shipping/transit/handling) and the inherent variability in the fiber core material.A review of the device history records was performed for the indicated lots for any deviations related to the reported failure mode of the complaint.The review confirms that the lots met all material, assembly and performance specifications; i.E.No ncr associated with reported failure mode.Labeling review: the instructions for use which is supplied to the end user with this catalog number contains the following statement "avoid damaging the fiber by striking, stressing or excessive bending.Do not coil the fiber tighter than a diameter of 16cm." 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.Reference (b)(4).

• Brand Name: VENACURE NEVERTOUCH FIBER
• Type of Device: VENACURE ENDOVENOUS LASER TREATMENT FIBER
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer (Section G): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587990
• MDR Report Key: 17334296
• MDR Text Key: 319396276
• Report Number: 1319211-2023-00048
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: H787114030010
• UDI-Public: H787114030010
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171921
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/15/2023

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
• Device Operator: Health Professional
• Device Model Number: 11403001
• Device Catalogue Number: 11403001
• Device Lot Number: 5777564
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/21/2023
• Initial Date FDA Received: 07/17/2023
• Supplement Dates Manufacturer Received: 08/07/2023
• Supplement Dates FDA Received: 08/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1