MAUDE Adverse Event Report: MEDTRONIC IRELAND ENDO ANCHOR SYSTEM - HELI-FX AAA; ENDOVASCULAR SUTURING SYSTEM

Model Number	SA-85
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: device decontaminated with cidex-opa pending further device testing to support the final product analysis findings.The applier returned with a partially loaded endoanchor visible in the housing.There was no damage observed to the applier.The handle was opened, and no fluid or blood was observed within the handle.No corrosion was observed to the circuit board or connector pins.All wires and connectors within the handle appeared to be intact and properly connected.The battery was removed and measured 8.14v.A new battery was attached, and the unit powered up with the blue error flashing, the forward light flashing and the back light unresponsive.The eprom was read and presented the following codes (locn x code): oax05 battery low detection, 0bx05 postrev, 0cx07 drive motor operation time-out, 00x17 fatal.The device was restarted in factory mode with the blue error light on, forward light flashing, back light on.On pressing the forward button, the endoanchor was deployed.A fractured section of an endoanchor was visible in the applier housing.The endoanchor was manually removed and another endoanchor loaded and deployed with no issue noted.The applier functionality was confirmed.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An heli-fx was attempted to be used in an unknown endovascular procedure.It was reported that during the index procedure, the first endo-suture was loaded and delivered successfully.On picking up second suture from the holding device it failed to load the endo-suture on multiple attempts.It was stated that the endo-suture was only loaded half way.Multiple attempts to reset the device was also failed.A second device was opened and the procedure completed.As per the physician the cause of the event can not be determined.No additional clinical sequalae were reported and the patient is fine.

• Brand Name: ENDO ANCHOR SYSTEM - HELI-FX AAA
• Common Device Name: ENDOVASCULAR SUTURING SYSTEM
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• MDR Report Key: 11567596
• Report Number: 9612164-2021-01152
• Device Sequence Number: 17195143
• Product Code: OTD
• UDI-Device Identifier: 00763000225933
• UDI-Public: 00763000225933
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K140036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/25/2021

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: 03/11/2022
• Device Model Number: SA-85
• Device Catalogue Number: SA-85
• Device Lot Number: 0010173832
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2021
• Initial Report FDA Received Date: 03/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1