MAUDE Adverse Event Report: ANGIODYNAMICS, INC. ALPHAVAC; ASPIRATION THROMBECTOMY CATHETER

Catalog Number	25302
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Hypovolemic Shock (1917)
Date of Event	05/16/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
The reported device has been disposed; therefore, it is not available to be returned to the manufacturer for evaluation.An investigation into the root cause for 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 angiodynamics clinical specialist reported a patient adverse event, occurring 4-5 hours after a procedure with an alphavac f18-85.The alphavac procedure was completed successfully; however, the patient expired 4-5 hours after the procedure, due to complications from an unrelated coronary angiogram procedure 2 days prior, on (b)(6) 2024.Access for that procedure was obtained via the right femoral artery, and subsequently, there were access complications/bleeding from that artery into the retroperitoneal space and scrotum.Bleeding from the access site was restarted the day of the alphavac procedure because the patient was given thrombolytics which made bleeding from the arterial stick site easier.Per the physician, the patient expired due to hemorrhagic shock via the femoral arterial access site and their expiration had nothing to do with the alphavac procedure or any angiodynamics device.
Additional Manufacturer Narrative
The customer's reported complaint description of patient expiration post alphavac procedure cannot be confirmed given the patient centric nature of this serious adverse event (sae).There were no reports of alphavac device malfunction during the procedure; therefore, the device was not returned for evaluation.The physician declared that the patient expired due to hemorrhagic shock from the femoral artery due to access for coronary angiogram procedure two days prior.Patient expiration had nothing to do with the alphavac procedure or any angiodynamics device.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: directions for use (10903657) are provided with this device and contain the following statements: indications for use the cannula is indicated for: · the non-surgical removal of thrombi or emboli from the venous vasculature · aspiration of contrast media and other fluids from the venous vasculature the cannula is intended for use in the venous system.· directions for use and manuals for the alphavac system and all related accessories should be read prior to use and devices used as indicated.· as with all medical devices, this device and ancillary equipment are to be used by trained physicians only.Specifically, this device is to be used only by medical personnel experienced with using surgical and/or percutaneous (seldinger) vascular access techniques as well as physicians trained and experienced in percutaneous, intravascular, diagnostic and interventional techniques requiring fluoroscopic or image guidance and visualization.Adverse events this device, as do all embolectomy systems and devices, has possible side effects, which include, but are not limited to infections, blood loss, thrombus formation, embolic events, vessel, ventricular or valvular damage and complications of percutaneous or surgical insertion techniques.These may occur if the directions for use are not followed.Possible complications include those normally associated with large bore surgical and/or percutaneous vessel catheterization/cannulation, anticoagulation, and application of intravascular introducer systems which include but are not limited to: blood loss/blood trauma, hemorrhage/bleeding, death.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: ALPHAVAC
• Common Device Name: ASPIRATION THROMBECTOMY CATHETER
• 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: 19499308
• Report Number: 1319211-2024-00055
• Device Sequence Number: 7833367
• Product Code: QEZ
• UDI-Device Identifier: H787253020
• UDI-Public: H787253020
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K240397
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 25302
• Device Lot Number: 5809160
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2024
• Supplement Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 06/10/2024
• Supplement Report FDA Received Date: 08/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/27/2023
• 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: Death
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 275 KG