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

Catalog Number 11403101

Device Problem Fracture (1260)

Patient Problem Burn(s) (1757)

Event Date 09/08/2022

Event Type  malfunction  

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 Description

An end user reported an issue with a fiber from a nevertouch direct procedure kit.During a procedure, the operator was holding the fiber, between thumb and finger, when it fractured approximately 250mm back from the tip.The operator received superficial burns on their thumb and was concerned the incident may repeat if there was an issue with the machine and cancelled the remainder of their appointments.The patient did not experience any adverse effects, harm, or require medical intervention because of this incident.

Event Description

Additional event information: the doctor self-treated the burn, which was reported to be a very small, pinpoint burn.The doctort did not experience any adverse effects, harm, or require medical intervention because of this incident.

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).

Manufacturer Narrative

Returned for evaluation was a nevertouch direct fiber.A visual review of the fiber noted that the fiber was fractured 27.2cm from the fiber tip.The fiber break at both ends shows the blue layer "buffer" is melted.At the break point, approximately 75% of the exposed glass core appears flat / smooth and the remainder of the core has a step like appearance.The entire length of the returned fiber assembly was stressed by bending it to approximately a 1" radius and no weak points were found.The appearance of the fiber glass core at the break point indicates that a combination of material variability and applied stress was associated with the glass core fracturing.The smooth section of the glass core at the break point most likely resulted due to some material variability that was associated with the initiation of a fracture when stress was applied.The step appearance indicates that complete separation of the glass core occurred after the integrity of the glass core was compromised to the point where it could not withstand the stress due the force applied during withdrawal of the fiber assembly.The customer's reported complaint of the fiber fractured and detached is confirmed.A review of the returned sample shows the glass core at the break of the fiber indicating that the fiber broke under a low level of stress.The root cause for the fiber detachment is a fracture of the glass core which allowed laser energy to escape and melt the buffer layer.Root cause of the glass core fracture is likely a combination of inherent material variability and the degree of applied force to that section of the fiber.The minor burn was a result of this fiber fracture where end user applied force to the shaft.Since there is no evidence of fiber mishandling in the area where the break occurred, it appears the most likely root case of the fractured glass core is a combination of material variability which made the glass core more susceptible to fracturing and the degree of applied force to that section of the fiber which resulted in the initiation of the fracture and complete separation of the fiber glass core.Root cause for the fiber fracture could not be definitively determined but is potentially related to low level of stress in glass fiber core in combination with force applied by end user.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.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.Prior to packaging, all components are inspected for damage.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." the user manual (man/31/0075), which is supplied to the end user with this unit, states "before using a fiber, check it carefully for any signs of damage during storage or transit.Protective caps should be in place over sma connectors.Do not use if there is any sign of damage." patient injury: the user manual (man/31/0075), which is supplied to the user with this unit contains the following warnings and statements: "clinical warnings: as with any conventional surgical operations, adverse reactions may occur following treatment", "irradiation of any substance or material other than the target treatment of varicose veins and varicosities may result in a laser burn", "contraindications: the venacure 1470 laser is contraindicated for: patients with thrombus in the vein segment to be treated · patients with an aneurysmal section in the vein segment to be treated · patients with peripheral artery disease as determined by an ankle-brachial", and, "potential complication: the potential for complications exists, including: vessel perforation; thrombosis; pulmonary embolism· phlebitis; hematoma· infection· skin pigmentation alteration· neovascularization· paresthesia due to thermal damage of adjacent sensory nerves· anesthetic tumescence· non-target irradiation· hemorrhage; necrosis; dehp exposure; skin burns and pain(this is not an exhaustive list.)".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 DIRECT PROCEDURE KIT
• 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 ; 5086587805
• MDR Report Key: 15454524
• MDR Text Key: 306333645
• Report Number: 1319211-2022-00038
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: H787114031015
• UDI-Public: H787114031015
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K171921
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/10/2022

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 Catalogue Number: 11403101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/08/2022
• Initial Date FDA Received: 09/20/2022
• Supplement Dates Manufacturer Received: 09/21/2022; 11/08/2022
• Supplement Dates FDA Received: 09/27/2022; 11/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2021
• 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