MAUDE Adverse Event Report: ANGIODYNAMICS ANGIOVAC; CARDIOPULMONARY BYPASS VASCULAR CANNULA

Catalog Number H965251860

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

Patient Problems Abnormal Blood Gases (1034); Death (1802); Multiple Organ Failure (3261)

Event Date 06/24/2015

Event Type  Death  

Event Description

Angiovac procedure on wednesday evening ((b)(6) 2015) to address thrombus (dvt) in legs and above and within ivc filter.There were no reports of angiovac cannula or circuit malfunction during the procedure.The angiovac cannula was inserted into the right ij and the reinfusion cannula was inserted into the left ij.At one point of the procedure, lost access to the left ij with reinfusion cannula and had to re-gain access.At the start of the case the patient's hemoglobin was 8.3 and they infused a unit of blood.Midway - 2/3 of the way through the procedure two more units of blood were given.Soon after the second unit was in, the anesthesiologist expressed concern that the patient's ph suddenly turned to a negative ph.(possible transfusion reaction?).Procedure was ~4 hours long and some undesirable intravascular material was able to be removed from the patient.A stenting was performed.At the conclusion of the case, the patient was stable, and went back to recovery/her room.It was indicated that dr.(b)(6) "felt good" about the result.Patient experienced an issue with ph levels on thursday, (b)(6) 2015.The patient expired on (b)(6) 2015 due to multiple organ failure.The used angiovac device was discarded at the hospital.(b)(4).

Manufacturer Narrative

Although no sample device will be returned for evaluation, the investigation into this event is on-going.Upon completion of the investigation, a supplemental medwatch will be submitted.(b)(4).

Manufacturer Narrative

The reported packaging lot 4892100 for angiovac cannula item # h965251860 had a purchased angiovac cannula component item number 10800060 (lots 599620 and 600109) packaged in it.A review of the device history records was performed by the supplier, (b)(4), 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 angiodynamics complaint report was reviewed for the angiovac product family for the failure mode "patient injury/death." no adverse trends were indicated.The use angiovac cannula 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: "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." and "- 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." no angiovac cannula device malfunction or performance issue was reported during the procedure, as such, no device was retained and returned for evaluation.As stated in the clinical review regarding the procedure, the blood transfusion and patient's ph levels likely contributed to the adverse event.(b)(4).Device not returned to manufacturer.

• Brand Name: ANGIOVAC
• Type of Device: CARDIOPULMONARY BYPASS VASCULAR CANNULA
• Manufacturer (Section D): ANGIODYNAMICS; marlborough 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: 4925748
• MDR Text Key: 6030317
• Report Number: 2952363-2015-00007
• Device Sequence Number: 1
• Product Code: DWF
• 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,Company Representative,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/26/2015

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Catalogue Number: H965251860
• Device Lot Number: 4892100
• Other Device ID Number: ANGIOVAC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/26/2015
• Initial Date FDA Received: 07/15/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2015
• 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