MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS ANGIOVAC; CARDIOPULMONARY BYPASS TUBING / PUMP

Catalog Number	H965251860
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pulmonary Embolism (1498); Death (1802)
Date of Event	05/26/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
A review of the device history records was performed for the indicated 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.The recent angiodynamics complaint report was reviewed for the angiovac product family and the failure mode "patient injury/death.No adverse trend was indicated.No used device was returned.Per the reporting physician, the device was not believed to have malfunctioned nor contributed to the patient's pe and subsuquent death.The directions for use provided with the angiovac contain the following cautions: "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", (b)(4).Device not returned to manufacturer.
Event or Problem Description
Angiodynamics has become aware of a patient death from complications from a pe.The pe occurred two days after an elderly male was being treated for svc syndrome with an angiovac.The physician, dr.(b)(6) has stated, in email, " i don't really think it was related to the device, i think we did pretty much everything we could." when asked if anything was done to resolve the pe at the time, he said, "we just put him on heparin, there was no procedure that would have been able to retrieve it or lyse it." details of the procedure are as follows: pre-case discussions included access planning and potential issues.The rfv was used for aspiration and the lfv was used for reinfusion.Initial venogram showed little clot per dr.(b)(6) but significant stenosis.Once the patient was heparinized and an act > 300 seconds obtained an 18 fr.Arterial reinfusion cannula was placed in the lfv and a 26 fr.Gore dryseal placed in the rfv.Under fluoroscopic guidance the cannula was placed in the mid right atrium and the flow optimized at 3.5 liters per min.The cannula was then advanced into the svc which resulted is no flow which was resolved by moving the cannula back towards the ostia.Several passes were made.Dr (b)(6) then angioplastied the svc with pta balloons, increasing in size to about a 16 mm.The left ij was also accessed and a wire passed to allow pta of the innominate vessels.Venography showed considerable improvement.The procedure was ending with no perioperative complications.The patients oxygen saturation remained stable and the etco2 was unchanged.The bubble trap canister showed a small piece of clot, dr.(b)(6) said that the svc had mostly chronic adherent material and in hindsight might have tried to do this case without angiovac.Once the cannulas were removed, dr.(b)(6) did not reverse the heparin initially and had his staff hold manual pressure.The staff had difficulty with venous compression of the femoral venotomy site, so anesthesia then gave 20 mg of protamine.

• Brand Name: ANGIODYNAMICS ANGIOVAC
• Common Device Name: CARDIOPULMONARY BYPASS TUBING / PUMP
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 6661295
• Report Number: 1317056-2017-00043
• Device Sequence Number: 197708
• Product Code: DWE
• UDI-Device Identifier: H965251860
• UDI-Public: H965251860
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K142607
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/21/2017

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
• Operator of Device: Physician
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: H965251860
• Device Lot Number: 5186934
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2017
• Initial Report FDA Received Date: 06/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death