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 Problem Non specific EKG/ECG Changes (1817)

Event Date 10/21/2020

Event Type  Injury  

Manufacturer Narrative

This medwatch is not to report a device malfunction, but to report an adverse patient event.As the reported defective device was not returned, angiodynamics is unable to perform a device evaluation.The product was not returned for evaluation since there was no report of angiovac device malfunction during the procedure.The customer's reported complaint description cannot be confirmed due to the nature of this patient adverse event; there were no reports of angiovac device malfunction during the procedure.The most likely root cause for the reported event was due to the patient condition.No correction is required since there was no reported device malfunction during the procedure, i.E.Device functioned as intended and did not directly contribute to patient adverse event.Pulmonary embolism (pe) is a potential anticipated procedural complication of an angiovac procedure; this is cautioned in the dfu.A review of the device history records was performed for the reported packaging and component lots for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly, and performance specifications.Labeling review: 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.Pulmonary embolism.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.(b)(4).

Event Description

This medwatch is not to report a product malfunction, but to report and adverse patient event that occured when an angiodynamics product was in use.An angiodynamics clinical specialist reported an embolic event occurred while supporting a case via (b)(6).The following was reported: "age of patient not confirmed.History of breast cancer.Came in for chemo and restless legs and dvt found.Admitted to the hospital and was screened for pulmonary embolisms.Found tumbling right atrial material.Angiovac procedure scheduled for following day.Transesophageal echocardiogram (tee) probe was in place.The material was still present upon investigation.Material appeared to be attached to the subvalular portion of the tricuspid valve and sitting in the right ventricle (rv).Pfo present per md and the potential of material embolizing across it was known by all and procedure room if procedure continued.The right internal jugular (rij) vein was accessed and a 6fr sheath was established while physician worked on right femoral vein (rfv) access.Right femoral vein (rfv) access was obtained and then upsized to arterial reinfusion cannula.Rij was upsized to a 26fr gore dry seal (gds) sheath.Heparin was given and in therapeutic range for continuation with angiovac.Circuit was then primed, run and confirmed air free.Circuit then attached to reinfusion cannula and the angiovac.Physician attempted to float a swan-ganz catheter across the tricuspid valve and into the rv with wire and was unable to successfully do so.After several attempts physician decided to look into left femoral vein (lfv) approach.Lfv access achieved and another 26fr sheath inserted.Angiovac inserted into gds in lfv and advanced up to the tricuspid valve annulus.Angiovac no quite long enough to pass through the valve.Pump turned on with flows of 2.0 established.Patient suddenly became hemodynamically unstable.Angiovac removed, cpr began.At this point patient was set up on veno-arterial ecmo circuit and angiovac portion of procedure concluded.Physician believes that material embolized to lungs." it was indicated that the reported device is not available to be returned to the manufacturer for evaluation.

• 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: 10828903
• MDR Text Key: 215905522
• Report Number: 1317056-2020-00179
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/12/2020

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 Expiration Date: 09/30/2022
• Device Model Number: 25194
• Device Catalogue Number: 25194
• Device Lot Number: 5595432R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/21/2020
• Initial Date FDA Received: 11/12/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention