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

Catalog Number	11403101
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the disposable device is not available to be returned to the manufacturer for evaluation.The results of the investigation will be sent via a follow up medwatch.Reference complaint (b)(4).
Event or Problem Description
An angiodynamics territory manager reported being informed of an incident involving a nevertouch direct procedure kit.It was reported that, during an evlt procedure, the introducer sheath was burnt inside of the patient's vein, causing the sheath to be severed.The patient was taken to the operating room to have the sheath surgically removed from her vein.It was reported the disposable device is not available for return to the manufacturer for a device evaluation.
Additional Manufacturer Narrative
As the reported defective device was not returned, angiodynamics is unable to perform a device evaluation.The complaint description cannot be confirmed due to no product being returned for evaluation.Without receiving a sample for evaluation a definitive root cause cannot be determined.A possible root cause for this event as determined by angiodynamics' manufacturing engineer, "from the information provided, it appears that the end user chose to leave the introducer sheath inside the vein during the procedure and did not begin withdrawing it in conjunction with the fiber assembly when the 16cm print mark became visible.This incident appears to be the result of the end user not properly monitoring for the position of the fiber assembly distal tip and withdrawing it into the introducer sheath while the laser was activated." 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 references the following statements: procedure: slide the introducer sheath out of the vessel and back along the fiber.Note: if the sheath is left inside the vessel during the procedure, upon visualization of the 16cm warning mark, begin removing the sheath from the vessel in conjunction with the fiber.Note: if use with the 65 cm trè-sheath* introducer is required in place of the introducer, align the back end of the trè-sheath hub with the center of the 72cm locating mark.Note: if a trè-sheath is used, confirm the fiber tip protrudes at least 2cm past the tip of the trè-sheath prior to lasing.Verify fiber tip position using ultrasound guidance.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: NEVERTOUCH DIRECT PROCEDURE KIT
• Common Device Name: VENACURE ENDOVENOUS LASER TREATMENT FIBER
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 10184369
• Report Number: 1319211-2020-00039
• Device Sequence Number: 908208
• Product Code: GEX
• UDI-Device Identifier: H787114031015
• UDI-Public: H787114031015
• Combination Product (Y/N): N
• 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: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 11403101
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2020
• Supplement Date Received by Manufacturer: 06/15/2020
• Initial Report FDA Received Date: 06/23/2020
• Supplement Report FDA Received Date: 09/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention