MAUDE Adverse Event Report: ANGIODYNAMICS ANGIOVAC; CATHETER, CANNULA & TUBING, VASCULAR,CARDIOPULMNARY BYPASS

Catalog Number UNKNOWN

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

Patient Problem Arrhythmia (1721)

Event Date 02/06/2020

Event Type  Injury  

Manufacturer Narrative

No product 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.No sample was returned for evaluation.No dhr review was conducted since there was no reported lot # and ship history lot review was not performed since item # is unknown.The cardiac arrhythmia issues that occurred during the procedure is an anticipated procedural complication of the angiovac procedure.This medwatch is not to report a device malfunction, but to report an adverse patient effect.There was no report of a device malfunction during the procedure.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: the angiovac cannula sample was not returned for evaluation since there was no reported device malfunction during the procedure.Directions for use (dfu, (b)(4)) 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, arrhythmias.A review of the angiodynamics complaint system noted no trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Complaint #: (b)(4).

Event Description

As reported: tee was placed and ra visualized prior to draping.The material was still present upon investigation.Material appeared to be quite mobile and attached to the tricuspid valve.Patient was then prepped and draped in sterile manner.The right internal jugular vein and right femoral vein access was obtained with micropuncture and ultrasound guidance.Heparin was given and both sites were upsized respectively.Rij to 26fr gore dryseal and rfv upsized to 18fr arterial reinfusion cannula.Act> 300 and circuit was then attached to the reinfusion cannula and the angiovac.Angiovac primed and inserted into rij.Baseline and threshold flows were established in the svc/ra junction at roughly 2.2/lpm.Physician advanced the angiovac towards the tricuspid valve to engage the material.Shortly after our attention was drawn to the ekg monitoring machine that showed an irregular arrythmia.The physician then performed several pericordial thumps, pulled angiovac back into gore dryseal after i prompted him to and then roughly 20 chest compressions.Patient broke out of irregular arrythmia and was back to normal sinus rhythm.Physician checked arterial line that patient had to make sure it wasn't an pulseless electrical activity event at this point.Anesthesiologist confirmed that patient had pulse.Tee imaging was then interrogated to see if material was still there.No material was shown on the tricuspid valve during imaging, i went over to bubble trap to check and material was indeed in the bubble trap.Physician liked the result and decided to end procedure.Blood in circuit given back to patient, all equipment removed and patient hemostasis achieved on access sites used.It was reported the defective disposable device is not available for return to the manufacturer.

• Brand Name: ANGIOVAC
• Type of Device: CATHETER, CANNULA & TUBING, VASCULAR,CARDIOPULMNARY BYPASS
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny
• Manufacturer (Section G): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny
• Manufacturer Contact: law ryan ; 10 glens falls technical park; glens falls, ny ; 7424488
• MDR Report Key: 9699593
• MDR Text Key: 192403516
• Report Number: 1317056-2020-00025
• Device Sequence Number: 1
• Product Code: DWF
• 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: 02/12/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2020
• Initial Date FDA Received: 02/12/2020
• 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: 32 YR