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

Catalog Number 25194

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

Patient Problem Perforation of Vessels (2135)

Event Date 10/12/2023

Event Type  Death  

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 the following patient issue during an alphavac procedure: "a 59-year-old female with a history of cancer and concern for metastasis presented with material in the ivc extending into the right atrium.In the pre-case planning discussion, the physician stated that there would be two parts of the procedure.In part one, the ct surgeon would use angiovac to aspirate material in the right atrium.He planned to access the right internal jugular vein for aspiration with angiovac and the left internal jugular vein for the blood return cannula.In part two, the vascular surgeon would use alphavac to aspirate material in the ivc.He planned to access the right femoral vein for aspiration.The patient was brought to the or for the procedure.Preprocedural vitals were stable.The patient was prepped and draped in a sterile fashion.Tee probe was introduced and confirmed moveable material in the right atrium extending down into ivc.The angiovac circuit was prepped and primed.The ct surgeon used ultrasound guidance to gain access into the right and left internal jugular veins and placed a small bore sheath in each vein.The patient was given heparin to obtain a therapeutic act.The left internal jugular vein was upsized to a 17f return cannula under fluoroscopy guidance using a stiff wire and serial dilation.The angiovac circuit was attached to the return cannula using a wet-to-wet technique and the cannula was flushed.The right internal jugular vein was upsized to a 26f gore dry seal under fluoroscopy guidance using a stiff wire and serial dilation.During dilation of the right internal jugular vein, specifically with the 20-french dilator, wire access was briefly lost and regained.After dilating up to 20f, the 26f gore dry seal was placed over the stiff wire under fluoroscopy.The wire and dilator were removed, and the physician was advised to aspirate and flush the gore dry seal sheath.It took several attempts to aspirate blood from the side port of the gore dry seal sheath.The angiovac cannula (with funnel collapsed in oversleeve) was advanced into the right atrium through the gore dry seal sheath and the cannula's funnel was advanced out of the oversleeve under fluoroscopy guidance.The centrifugal pump was started at 1 lpm and gradually increased to 3 lpm.The angiovac cannula funnel was not visualized in the right atrium under tee guidance.Pump time was around thirty minutes.Unable to visualize cannula engagement with the material under tee guidance.Angiovac circuit was clamped and the cannula was removed from gore dry seal.Right ij and left ij sheaths were left in place during the second part of the procedure.The vascular surgeon obtained access to the right femoral vein under ultrasound guidance.A stiff wire was placed through the right femoral vein and serial dilation was performed under fluoroscopy guidance.A second 26f gore dry seal was placed in the right femoral vein.Contrast was flushed through the gore dry seal and a venogram of ivc was obtained.The alphavac cannula with obturator was placed over the stiff wire and through the gore dry seal and terminating distal to ivc material.The wire and obturator were removed and the alphavac funnel was advanced out of oversleeve and into ivc material.Several pulls of alphavac were performed and ivc material was removed.Alphavac cannula was removed from the gore dry seal.Contrast was flushed through gore dry seal and a venogram of ivc was obtained.After completion of the two parts of the procedure, all vascular access sheaths were removed from the patient.When the right internal jugular vein 26f gore dry seal was removed there was a drop in the patient's blood pressure and the decision was made to convert to sternotomy." in the post procedure debrief the physician presumes that the svc was perforated during dilation of the right internal jugular vein and the gore dry seal sheath acted as a tamponade of the perforation during the procedure.When the gore dry seal sheath was removed from the right internal jugular vein the perforation was exposed and the patient began to decompensate." ultimately, the patient expired.The physician did not state that there was any type of malfunction or deficiency with the angiovac device that contributed to this event.The angiovac device was used to the instructions for use (ifu) by dr.(b)(6) (ct surgery) in the right side of the heart.The alphavac device was used to the ifu by dr.(b)(6) (vascular surgery) in the ivc.This was dr.(b)(6) third time using the angiovac device in the right side of the heart.His previous two cases were pacemaker lead vegetations and he worked in tandem with an ep physician.In his previous two cases, the right and left femoral veins were accessed for the angiovac device.In this recent case he accessed the right and left internal jugular veins for the angiovac device-- this was his first-time using ij access for the angiovac device.

Manufacturer Narrative

No product was returned for evaluation since there was no report of angiovac or alphavac system malfunction during the procedure.The customer's reported complaint description cannot be confirmed due to the nature of this patient serious adverse event; there were no reports of angiovac (or alphavac) device system malfunction during the procedure.As such, no sample was returned for evaluation.It was concluded that the angiovac (and alphavac) device was unrelated to the patient's vessel perforation issue, which is an anticipated procedural complication.In the post procedure debrief the physician presumes that the svc was perforated during dilation of the right internal jugular vein and the gore dry seal sheath acted as a tamponade of the perforation during the procedure.When the gore dry seal sheath was removed from the right internal jugular vein (at the end of the procedure) the perforation was exposed and the patient began to decompensate.A sternotomy was performed but ultimately, the patient expired.The physician did not state that there was any type of malfunction or deficiency with the angiovac device that contributed to this serious adverse event.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.- blood loss/blood trauma.- hemorrhage.- 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
• 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: 18041484
• MDR Text Key: 326990588
• Report Number: 1317056-2023-00146
• 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,Followup
• Report Date: 12/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 25194
• Device Lot Number: 5754610
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2022
• 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): Death
• Patient Age: 59 YR
• Patient Sex: Female