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

Catalog Number H965251850

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

Patient Problems Pulmonary Embolism (1498); Death (1802)

Event Date 12/14/2016

Event Type  Death  

Manufacturer Narrative

Although no sample will be returned to angiodynamics for evaluation, the investigation into this event is on-going.Upon completion of the investigation, a supplemental medwatch will be submitted.(b)(4).Device not returned to manufacturer.

Event Description

As reported by angiodynamics' clinical specialist: patient's indication for angiovac procedure was right atrial thrombus.Patient's co-morbidities were endocarditis, was septic, and hx of ivdu.Patient was stable at time of procedure, but with high venous pressures per md.Pulmonary embolism occurred during case.When the pe occurred is unknown, as there was no visualization of the embolization.The pe was diagnosed at the end of the case by md based on end tidal co2 and saturations decreasing.The angiovac was out of the patient at that time.The patient's condition at that time was "stable." follow-up with the physician regarding the patient's current status has indicated that the patient expired one week after the procedure due to her overall poor health.The md did not attribute the patient's death to the angiovac device.((b)(4)).

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 angiodynamics complaint report was reviewed for the angiovac product family and the failure mode "patient injury/death." no adverse trend was identified.Although no used device was returned for evaluation, it is not believed that a device malfunction occurred: information from the physician received by angiodynamics' sales representative indicated that " the patient expired 1 week after the procedure due to her overall poor health status.The md did not attribute the patient's death to the device." directions for use provided with the angiovac cannula include the following: "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.

• Brand Name: ANGIOVAC / ANGIODYNAMICS
• Type of Device: CATHETER, CANNULA & TUBING, VASCULAR
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• Manufacturer (Section G): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• Manufacturer Contact: law ryan ; 10 glens falls technical park; glens falls, NY 12801 ; 5187424488
• MDR Report Key: 6237033
• MDR Text Key: 64342891
• Report Number: 1317056-2017-00004
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: H965251850
• UDI-Public: H965251850
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Physician
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: H965251850
• Device Lot Number: 5020900
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2016
• Initial Date FDA Received: 01/10/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2016
• 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
• Patient Age: 35 YR