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

Catalog Number	H965251860
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	08/06/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
A review of the device history records was performed for the indicated packaging and assembly 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 july 2018 angiodynamics complaint report was reviewed for the angiovac product family and the failure mode "patient injury/death." no adverse trend was indicated.The angiovac cannula was not returned for evaluation as there was no report of device malfunction.As stated by the physician, the cause of death was believe to have been a "hemorrhage related to ivc and anticoagulation." the directions for use provided with the angiovac device contain 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".(b)(4).
Event or Problem Description
As reported: " patient expired during angiovac procedure.A wire was advanced through the 16fr sheath and a new sheath was advanced over the wire.While advancing the new sheath the physician had difficulty advancing into the ivc, but after some manipulation the sheath was positioned in the ivc superior to the ivc filter and past the ra/ivc junction.During placement the pt.'s systolic pressure began to drop into the 50's mm/hg.Anesthesia gave a pressor to boost the systolic pressure but it continued to drop.When the systolic pressure dropped into the 40's mm/hg the pt.Began to drop her o2 sats.O2 saturation dropped to 50%-60% and physician called a full code.Physician ended the angiovac procedure and life saving measures were initiated by the code team." response from dr.(b)(6)- cause of death most likely " hemorrhage related to ivc and anticoagulation.".

• Brand Name: ANGIODYNAMICS / ANGIOVAC
• Common Device Name: CATHETER, CANNULA & TUBING, CARDIOPULMONARY
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 7842699
• Report Number: 1317056-2018-00167
• Device Sequence Number: 11051708
• Product Code: DWF
• UDI-Device Identifier: H965251860
• UDI-Public: H965251860
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K142593
• 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): 09/04/2018

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: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: H965251860
• Device Lot Number: 5324631
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2018
• Initial Report FDA Received Date: 09/04/2018
• 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
• Patient Age: 49 YR