MAUDE Adverse Event Report: ANGIODYNAMICS, INC. VENACURE EVLT; POWERED LASER SURGICAL INSTRUMENT

Model Number	11403003
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported device has been returned to the manufacturer for evaluation.An investigation into the root cause for this event 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 the following issue with a never touch 45cm kit w/gripper and rfid t: "after procedure done on patient, dr.(b)(6) looked at the blue dilator as he always does as he puts it down and noticed that the end piece was missing.He told russell our ultra sound tech to look and see if he could see anything, there was a piece of the blue dilator in patients right upper leg.Dr.(b)(6) instructed patient what was happening.Dr.(b)(6) used 3cc of 2% lidocaine, 11 blade scalpel and made an incision into patients right upper leg.Dr.(b)(6) had to use hemostats to grab the vein and the blue dilator was located.Dr.(b)(6) pulled fragment out of the vein and he put in two stitches, the leg was cleaned and antibiotic cream applied with steri strips and 4 x 4 dressing.Antibiotic called in for patient." an angiodynamics clinical support manager contacted the end user for additional information.The following step-by-step procedure details were obtained: 1.Vein was accessed and venotomy performed before the 21ga needle was removed.2.Sheath/dilator inserted over the wire and into the target vein (us tech did not believe a second venotomy was done) 3.Physician had difficulty removing the dilator/wire from the sheath but did remove the dilator and placed it on the sterile field.4.Laser fiber was inserted and vein was treated.5.At the end of the procedure, physician noticed that the tip was missing from the dilator.6.Ultrasound was utilized to locate the tip inside the treated vein.7.Cut down performed to retrieve the dilator tip.The patient is, reportedly, doing well and did not sustain any lasting adverse effects or harm.
Additional Manufacturer Narrative
The customer's reported complaint description of "the end of the blue dilator was missing" was confirmed.The returned dilator was noted to have been "cut" and 1.6cm of the tip was not returned.Based on the clinical review of the event, the root cause of what device might have cut the distal tip of the blue dilator is unknown.Inadvertent nick by scalpel is the likely root cause but procedure event details do not align with venotomy being performed at the time the blue dilator/sheath was inside of the vein entry site.A device history record review of the packaging/dilator lots revealed no quality related issues or manufacturing deficiencies at the time of manufacture.Labeling review: the instructions for use (16650393-01), which is supplied to the end user with this catalog number, states: "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.Clinical safety and effectiveness data is not available for other fiber tip designs and diameters.Prior to and during use, avoid bending the introducer sheath and dilator as this can cause kinks and damage".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 EVLT
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): ANGIODYNAMICS, INC.; 603 queensbury avenue; queensbury NY 12804
• Manufacturer (Section G): ANGIODYNAMICS, INC.; 603 queensbury avenue; queensbury NY 12804
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587990
• MDR Report Key: 20439589
• Report Number: 1319211-2024-00069
• Device Sequence Number: 8275513
• Product Code: GEX
• UDI-Device Identifier: H787114030030
• UDI-Public: H787114030030
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K231945
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2024

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 Model Number: 11403003
• Device Lot Number: 5827327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2024
• Supplement Date Received by Manufacturer: 12/02/2024
• Initial Report FDA Received Date: 10/14/2024
• Supplement Report FDA Received Date: 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown