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

Model Number 25193

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

Patient Problems Cardiac Arrest (1762); Hemorrhage/Bleeding (1888); Perforation of Vessels (2135)

Event Date 11/28/2022

Event Type  Injury  

Manufacturer Narrative

It was reported that the disposable device 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 Description

An angiodynamics clinical specialist reported a wire perforation occurred during a procedure.A patient was admitted for removal of large right ventricular mass.The patient was brought into the hybrid room and placed supine on the procedural table.General anesthesia was administered, and the patient's right neck and bilateral groins, prepped and draped in a sterile manner. pre-procedure: transesophageal echo (tee) revealed a large mass in the right ventricle.Access was obtained in the right internal jugular vein (rij) with a 22fr gore dryseal. a 16fr arterial return cannula was placed and secured in the right femoral vein.  the physician stated he wanted to use the angiovac for this procedure.The 22fr gore dryseal was removed and a 26fr goredryseal was successfully placed in the right ij.The 16fr return cannula was attached to the primed angiovac circuit.An amplatz super stiff wire was placed in the inferior vena cava (ivc). the c20 angiovac was prepped and attached to the primed circuit and flushed forward prior to introduction over the wire into the 26fr gore dryseal.The angiovac was introduced over the amplatz super stiff wire into the ivc.The funnel was deployed and the 26fr gore dryseal and angiovac retracted into the right atrium.Several attempts to cross the tricuspid valve were made unsuccessfully. a j-curved bentson wire was placed through the angiovac touhy borst into the left pulmonary artery as confirmed on tee. several attempts were made unsuccessfully to cross the valve with the angiovac. the physician's elected to place a amplatz super stiff wire through the touhy borst and buddy wire the pulmonary artery.Several attempts to cross the valve with the angiovac over both wires in the pulmonary artery were unsuccessful.The physician's elected to remove the j-wire bentson and place the angiovac obturator over the amplatz super stiff wire. the obturator tracked along the wire path into the left pulmonary artery. anesthesiologists could not confirm wire or obturator through the tricuspid valve on echo.The physician's elected to remove the angiovac and reshape the gore dryseal to allow passage through the valve.Once the angiovac and obturator were retracted into the right atrium, the anesthesiologist informed the physicians of a significant cardiac effusion and drop in blood pressure (49/37/(41) hr 114. chest was prepped and pericardiocentesis performed. multiple extractions of pericardial blood was removed however, the cardiac effusion remained unresolved.The physician's elected to open repair the perforation.After opening the chest, a large tear was noted at the ra ivc junction.The physician's stated the tear was from the obturator being advanced over the wire through the perforation. the perforation was successfully repaired and patient's vital signs returned to pre-procedure levels.(145/65 hr 90). it was reported the angiovac had never been activated.Angovac procedure was cancelled. the patient was reported as stable post event.

Manufacturer Narrative

As the reported device was not returned, angiodynamics is unable to perform a device evaluation.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 serious adverse event (vessel perforation).There were no reports of angiovac device malfunction during the procedure, pump was not even turned on.No device was returned for evaluation.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; damage to vessel; ventricular perforation.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
• 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: 15996038
• MDR Text Key: 305607314
• Report Number: 1317056-2022-00146
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: H965251930
• UDI-Public: H965251930
• 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,Followup
• Report Date: 02/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: 25193
• Device Catalogue Number: 25193
• Device Lot Number: 5730741
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2022
• 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: 61 YR
• Patient Sex: Male