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

Model Number	11403013
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported device has yet to be returned to the manufacturer for a device evaluation.An investigation into the root cause for product problem is currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference: (b)(4).
Event or Problem Description
An end user reported an issue with a 65cm nevertouch frs.018 procedure kit.It was reported that the "tip broke off" during the procedure.The laser catheter was removed and then noticed broken tip on the sterile field.The tip had remained inside the catheter.The patient did not experience any adverse effects, harm, or require medical intervention as a result of this incident.It was indicated the reported device is available for return to the manufacturer for a device evaluation.
Additional Manufacturer Narrative
Returned for evaluation was a fiber gold tip (loose in the bag) and a tre-sheath (missing tip).A visual review of the fiber noted that the gold tip was returned (fiber was not returned) with dried blood, the returned sheath was noted with the tip missing (which was not returned) also noted the sheath tip end had slight stretching.There are crimp marks on the proximal end of the gold tip tube indicating it was properly secured to the fiber.The quartz ferrule is still inside the gold tip tube indicating the fiber glass core broke at the quartz ferrule / fiber glass core weld joint.The quartz ferrule is still inside the gold tip tube indicating the fiber glass core broke at the quartz ferrule / fiber glass core weld joint.The root cause of the tip detaching was due to handling damage during use.Per the product manufacturing engineer's evaluation: from the information provided, it appears that the gold tip tube separation occurred before the tre sheath was withdrawn from the patient's vein since the gold tip tube was in the sheath when the sheath was removed from the patient.With that being the case, it seems that an attempt was made to withdraw the fiber assembly back through the tre sheath while the fiber assembly and tre sheath were still in the patient's vein.The large buildup of dried blood on the gold tip tube prevented it from being withdrawn into the tre sheath.The amount of force applied to the fiber assembly during the attempted fiber withdrawal resulted in the gold tip tube being lodged in the distal end of the tre sheath and ultimately a fracture at the fiber glass core / quartz ferrule weld joint which resulted in separation of the gold tip tube from the fiber assembly.The slightly stretched / elongated appearance of the tre sheath shaft at the tapered tip / shaft interface indicates a significant tensile force was applied to the tapered tip which resulted in the tip separating from the shaft.I believe that a significant amount of tensile force was applied post procedure to remove the gold tip tube from the tre sheath and during that effort separation of the tre sheath tapered tip most likely occurred.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.A review of the 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 "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 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
• Common Device Name: VENACURE ENDOVENOUS LASER TREATMENT FIBER
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 11648316
• Report Number: 1319211-2021-00022
• Device Sequence Number: 17018238
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2021

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: 11/30/2023
• Device Model Number: 11403013
• Device Catalogue Number: 11403013
• Device Lot Number: 5653500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2021
• Supplement Date Received by Manufacturer: 03/22/2021
• Initial Report FDA Received Date: 04/12/2021
• Supplement Report FDA Received Date: 04/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1