MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS ANGIOVAC; CATHETER, CANNULA & TUBING, CARDIOPULMONARY

Model Number	25194
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Exsanguination (1841)
Date of Event	07/14/2023
Type of Reportable Event	Death
Additional Manufacturer Narrative
It was reported that the disposable device was discarded by the user and 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(b)(4).
Event or Problem Description
An angiodynamics senior territory manager reported a patient adverse outcome, following an angiovac procedure.The angiovac c180 was chosen to remove tricuspid valve vegetation in a chronically ill patient.There was no device malfunction and the procedure was performed in accordance with the ifu (instructions for use.) the angiovac was reported to have been very successful in removing vegetation and performed as intended.The patient remained stable throughout the procedure; however, 6 hours following completion, the patient experienced a pulmonary bleed/ hemorrhage.The patient recovered until a second hemorrhage occurred approximately 24 hours later, resulting in the patient ultimately expiring.Patient was reported to be an iv drug user with several comorbidities including: infective endocarditis of tricuspid valve causing stenosis of prosthetic valve, hiv, hepatitis c, mrsa and multiple lung abscesses as a result of "throwing" a blood clot.The physician believes that the adverse outcome is a result of the patient's multiple comorbidities and is unrelated to the angiodynamics device.
Additional Manufacturer Narrative
Reference (b)(4).
Event or Problem Description
Additional information received: patient initials, weight, date of birth and confirmed date of death.Patient expired at 18:08.An autopsy was refused by the medical examiner.
Additional Manufacturer Narrative
As the reported device was not returned, angiodynamics is unable to perform a device evaluation.The customer's reported complaint description cannot be confirmed due to the nature of this patient serious adverse event (pulmonary hemorrhage); there were no reports of angiovac device malfunction during the procedure, therefore, no device sample was returned for evaluation.There was no reported angiovac device malfunction during the procedure, i.E.Device functioned as intended.Hemorrhage is a potential anticipated procedural complication of an angiovac procedure; this is cautioned in the dfu.The patient expiration is potentially a result of the patient's co-morbidities.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 angiovac cannula sample was not returned for evaluation since there was no reported device malfunction during the procedure.Directions for use is provided with this device and contains the following statements: warnings: - selection of the patient as a candidate for use with this device and for such procedures as it is intended is the physicians' sole responsibility.The outcome is dependent on many variables including, patient pathology, surgical procedure, and perfusion procedure/technique.The benefits of use of this device must be weighed against the risks including risks of systemic anticoagulation and must be assessed by the prescribing physician.- 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 initiating and monitoring extracorporeal bypass and by physicians trained and experienced using surgical and/or percutaneous (seldinger) vascular access techniques.Adverse events: this device, as do all extracorporeal blood vessel 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 instructions for use are not followed.Possible complications include those normally associated with large bore surgical and/or percutaneous vessel catheterization/cannulation, anticoagulation, extracorporeal circulation and application of intravascular introducer systems which include but are not limited to: - death - arrhythmias - pulmonary embolism - hemorrhage.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: ANGIODYNAMICS ANGIOVAC
• Common Device Name: CATHETER, CANNULA & TUBING, CARDIOPULMONARY
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• Manufacturer (Section G): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587990
• MDR Report Key: 17364255
• Report Number: 1317056-2023-00094
• Device Sequence Number: 5226516
• Product Code: DWF
• UDI-Device Identifier: H965251940
• UDI-Public: H965251940
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K142593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/07/2023

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 Expiration Date: 06/30/2024
• Device Model Number: 25194
• Device Catalogue Number: 25194
• Device Lot Number: 5738598
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2023
• Supplement Date Received by Manufacturer: 07/20/2023; 07/31/2023
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 08/02/2023; 08/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: 30 YR
• Patient Sex: Male
• Patient Weight: 75 KG