MAUDE Adverse Event Report: ANGIODYNAMICS ANGIOVAC; CATHETER, CANNULA AND TUBING, VASCULAR

Catalog Number VTX-3022

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Stroke/CVA (1770); Death (1802); Perforation (2001); Cardiac Tamponade (2226); Sudden Cardiac Death (2510); Cardiac Perforation (2513)

Event Date 04/20/2015

Event Type  Death  

Event Description

As reported by the physician, "during treatment of an acute massive pe (tumor thrombus during nephrectomy) yesterday, the pt suffered an rvot perforation during passage of the angiovac aspiration cannula, over the wire, with subsequent cardiac tamponade and need for emergency ecmo and surgical repair.The pt subsequently had a stroke and died." the used device was discarded by the hosp.

Manufacturer Narrative

The investigation into this event is on-going.Upon completion of the investigation, a supplemental medwatch will be submitted.(b)(4).

Manufacturer Narrative

The customer did not report a lot number for the reported event.Based on the attached ship history report (shr) obtained from (b)(4), the customer received two (2) lots (# 107160 and 107286) for item number vtx-3022 prior to the reported procedure date of (b)(6) 2015.A review of the device history records was performed by (b)(4) (supplier) for packaging lots 107160 and 107286 for any deviations related to the reported defect of the complaint.Their review showed that there were no observations that could have contributed to this event.The angiodynamics complaint report was reviewed for the angiovac product family for the failure mode "patient injury/death.No adverse trends were identified.The angiovac cannula sample was not returned for evaluation since there was no reported device failure.Therefore, it cannot be determined if the cannula was used in accordance with its labeling.Directions for use is provided with this device and contains the following statements: "adverse affects: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 damage and complications of percutaneous or surgical insertion techniques.These may occur if the instructions for use are not followed." a conference call between the angiodynamics medical director and the reporting physician (dr.(b)(6)) revealed the following information: dr.(b)(6) is experienced in using the angiovac cannula with 20+ cases performed.Patient was in their 80's and had stents in heart.History of renal cancer.Echo showed large mass in pa; 9cm mass/tumor from main pa to right pa.Reinfusion cannula was placed in right groin and gen 1 angiovac was placed in neck.The angiovac cannula was passed through the heart into the pa twice (2 passes).Circuit/cannula broke down - became clotted hence the need to pull back and attempt 2nd pass.A 2nd pass advanced back thru the rvot; did both passes over the guidewire and did not lose guidewire access between 1st and 2nd pass.Felt resistance on the 2nd pass, none felt on the 1st pass; took same path - kept wire access.Flanges/petals of the angiovac cannula tip were down (deflated) during both passes.A 1/2cm laceration (not a puncture) was observed in rvot during repair; anterior slit.Root cause is likely something sharp but source is unknown as there are no sharp edges on cannula.(b)(4).Device not returned to manufacturer.

• Brand Name: ANGIOVAC
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR
• Manufacturer (Section D): ANGIODYNAMICS; maritborough MA
• Manufacturer (Section G): ANGIODYNAMICS; 26 forest street; marlborough MA 01752
• Manufacturer Contact: law ryan ; 10 glens falls technical park; glens falls, NY 12801 ; 5187424488
• MDR Report Key: 4795697
• MDR Text Key: 21551901
• Report Number: 2952363-2015-00004
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091304
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: VTX-3022
• Other Device ID Number: ANGIOVAC CANNULA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2015
• 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): Death