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

Catalog Number H965251860

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

Patient Problems Pulmonary Embolism (1498); Low Blood Pressure/ Hypotension (1914)

Event Date 11/19/2015

Event Type  Injury  

Manufacturer Narrative

Although no sample device will be returned for evaluation, the investigation into this event is ongoing.Upon completion of the investigation, a supplemental medwatch will be submitted.

Event Description

As reported, by angiodynamics clinical specialist regarding an angiovac procedure of the ivc and iliac vein clot: "after clearing most of the clot out of the ivc and both iliac veins, the patient became hypotensive and eventually cpr was initiated.A pe was suspected and the patient was placed on ecmo.After 20 minutes of cpr, the patient stabilized and was moved to the icu for observation".There was no indication of malfunction on the part of the angiovac.No device sample is expected to be returned.

Manufacturer Narrative

The reported packaging lot 4876626d for angiovac cannula item # h965251860 had a purchased angiovac cannula component 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 and the failure mode "patient injury / death." no adverse trend was 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: "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." and "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." the end user hospital reported that there was a patient adverse event (cardiac complications as a result of pe) during the angiovac procedure, but they did not report a device malfunction.No sample was returned for evaluation.The likely root cause of the adverse event is operational context within the procedure as a pe is an anticipated complication as referenced in the dfu.(b)(4).Device not returned to manufacturer.

• Brand Name: ANGIOVAC
• Type of Device: CARDIOPULMONARY BYPASS VASCULAR CANNULA
• Manufacturer (Section D): ANGIODYNAMICS, INC.; 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: 5326429
• MDR Text Key: 34418879
• Report Number: 2952363-2015-00011
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/19/2015

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: 04/30/2017
• Device Catalogue Number: H965251860
• Device Lot Number: 4876626D
• Other Device ID Number: ANGIOVAC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/19/2015
• Initial Date FDA Received: 12/17/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention