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

Model Number 25194

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pulmonary Embolism (1498); Cardiac Arrest (1762); Decreased Respiratory Rate (2485)

Event Date 12/27/2021

Event Type  Injury  

Manufacturer Narrative

This medwatch is not to report a device malfunction, but to report an adverse patient issue during procedure.There was no report of a device malfunction during the procedure.As the reported defective device was not returned, angiodynamics is unable to perform a device evaluation.The customer's reported complaint description of patient thrombosis/embolism that resulted in cardiac arrest cannot be confirmed given the nature of the patient serious adverse event.No angiovac cannula/circuit was returned for evaluation as there was no reported device malfunction during the procedure.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.It cannot be determined if device was used in accordance with its labeling.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: distal embolization of thrombus ,pulmonary embolism ,arrhythmias ,and 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).

Event Description

A clinical specialist reported an end user experienced an issue when using an angiovac c180 device.The patient was brought into room and tee performed.Tee identified the material on the tricuspid valve.Pre-case, the patient sats were in 70's, hypotensive, and suffering from cardiogenic shock.The patient was prepped in sterile fashion.Access attempted in rij with no success, so the physician decided to go right femoral vein for aspiration and left femoral vein for return.Upon gaining access, the physician was unable to get 26fr gore dryseal to fit the right femoral vein so he decided to place the return there and the 26fr gore dry seal in the left femoral vein.Heparin was administered, and act was above 300.Angiovac connections were established and everything was confirmed to be air free.Angiovac was inserted in the patient and positioned above tricuspid valve material.The pump was turned on and angiovac began to debulk the material.As they went up on flows, material was still continuing to be debulked and suddenly physician realized o2 sats dropped and couldn't feel pulse.The angiovac was immediately pulled into ivc, epinephrine given, and cpr began.The patient appeared to be in cardiac arrest.On tee the right ventricle could be seen as barely moving.The physician operating the tee suspected that patient suffered from acute rv failure due to something embolizing to the lungs.The patient continued to receive norepinephrine, vasopressin, and blood for volume.The patient then placed on va ecmo where she became stable and sent to icu.Hr prior to concluding case was 90, map of 79, and o2 sat 88.The patient was reported as stable post procedure and will recover in the icu.There was no allegation by the physician that the angiovac device caused or contributed to the event.

• Brand Name: ANGIODYNAMICS / ANGIOVAC
• Type of Device: CATHETER, CANNULA & TUBING, CARDIOPULMONARY
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny 12801 NY 12801
• Manufacturer (Section G): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny 12801 NY 12801
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587805
• MDR Report Key: 13257472
• MDR Text Key: 285702332
• Report Number: 1317056-2022-00005
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: H965251940
• UDI-Public: H965251940
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142593
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/14/2022

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
• Device Operator: Health Professional
• Device Model Number: 25194
• Device Catalogue Number: 25194
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/27/2022
• Initial Date FDA Received: 01/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR
• Patient Sex: Female