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

Model Number 11403002

Device Problem Fracture (1260)

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

Event Date 07/06/2023

Event Type  malfunction  

Manufacturer Narrative

As the reported device was not returned, angiodynamics is unable to perform a device evaluation.Although no sample was provided, the customer provided photos, which shows the fiber tip was fractured/detached and there was burnt material of the drape/gown.The customer's reported complaint of the fiber fractured and detached was confirmed via attached photos provided by the customer.In addition, the complaint description that the drape was burnt is also confirmed via the provided photos.Although the complaint was confirmed, a definitive root cause cannot be determined without receiving the complaint sample for evaluation.A potential root cause is handling damage to fiber during prep of procedure.This is deemed to be an isolated incident and end user error may be a contributing factor.No in-service education is warranted since they do not use and angiodynamics laser generator.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." 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).

Event Description

A user facility's physician reported that during evlt procedure preparation using a nevertouch 65cm kit w/gripper and rfid tag, the evlt fiber was connected to the vascular solutions varilase unit and placed down on top of a folded gown on the procedure table.It was reported that upon connecting the fiber to the power source, the tip fractured off and burned the folded gown.The physician reported that no energy had been applied through the fiber, nor had a test fire been performed prior to this occurring.The physician decided to continue using the same fiber and inserted it into the patient without the tip.The procedure was completed with no vein closure.The patient did not experience any harm, adverse events, or require any medical intervention as a result of this event.

Manufacturer Narrative

The complaint sample was returned to angiodynamics for evaluation by the end user.The investigationis in process and the results will be sent in a follow up report.Reference (b)(4).

Manufacturer Narrative

Returned for evaluation was 1 fiber, gold tip detached and pieces of the blue gown.The fiber breaking point shows the fiber buffer to what appears to be melted, in addition the returned gold fiber tip shows blue "melted" matter which is most likely the melted gown as reported.Engineer's review: a review of the complaint sample indicated that the gold tip had been separated from the fiber and the buffer layer at the distal end of the fiber, though intact, had been significantly melted.The gold tip was coated in burned material, presumably from the drape.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.Engineer's evaluation: the fiber cannot transmit laser energy if not supplied with it, so it can reasonable be determined that the fiber had been connected to a laser source and energized outside the patient, burning the drape material and melting the buffer layer causing the tip to separate from the fiber.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.The customer's reported complaint of the fiber fractured and detached was confirmed.In addition, the complaint description that the drape was burnt is also confirmed.The possible root cause could have been that the fiber must have been energized by the generator in order for energy to burn the drape and melt the fiber buffering layer.The returned fiber showed charring of drape material on the outside of the gold tip, which is in line with the event description.The separation of the gold tip from the fiber shaft was a result of the buffering layer being melted from the outside toward the inside, i.E.Heat from burning drape.There is no indication that the fiber was fractured resulting in the buffering layer being melted from the inside toward the outside.It cannot be determined if fiber was used inside the patient after the detachment of the gold tip.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." 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." hardware unit review: this device has a related angiodynamics' hardware unit, however, the serial number of the evlt laser generator used during the procedure was not reported; a review of hardware service order history records in not required.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: 17364252
• MDR Text Key: 319658092
• Report Number: 1319211-2023-00056
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: H787114030020
• UDI-Public: H787114030020
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/18/2023

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: 11403002
• Device Catalogue Number: 11403002
• Device Lot Number: 5780302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/07/2023
• Initial Date FDA Received: 07/20/2023
• Supplement Dates Manufacturer Received: 08/14/2023; 10/17/2023
• Supplement Dates FDA Received: 08/17/2023; 10/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2023
• 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
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 104 KG