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

Catalog Number H965251860

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

Patient Problem Pulmonary Embolism (1498)

Event Date 11/08/2016

Event Type  Injury  

Manufacturer Narrative

Although a ship history report (shr) was generated for this complaint, a review of the dhrs are not required for this event.There was no report of device malfunction or performance issue during the procedure.Duke empirical is a contract manufacturer of the angiovac cannula for angiodynamics, no informational scar is required.The angiovac cannula sample was not returned for evaluation since there was no reported device failure.It cannot, therefore, be determined if the cannula was used in accordance with its labeling.The physician's assessment of the relationship of the adverse event to the device is that they are unrelated.Based on the reported event description, the root cause for further medical intervention (surgery) was due to the embolization of the undesirable intravascular material (uim) after it was broken up by an adjunct device.Directions for use (dfu) 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.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.(b)(4).Device discarded at hospital.

Event Description

Pt.Was prepped and draped in a sterile manner.A 26fr gore dry seal sheath was introduced into the rij, and a 26fr gore dry seal sheath was introduced into the rfv.A 17fr arterial re-infusion cannula was introduced into the rfv through the gore dry seal sheath.A 6fr sheath was introduced into the rfv for adjunctive devices, and a 10fr sheath was introduced into the lfv for ice.A 5fr sheath was also introduce into the lfa as a precautionary measure.The av cannula was then advanced over an amplatz super stiff wire to the svc / ra junction, and funnel was deployed.An act greater than 300 seconds was confirmed, circuit was primed, and then optimal flow was achieved (3.0l).The av cannula was advanced into the ra and the uim was engaged where we got "chatter" and our flow rates fluctuating from 1l - 3.0l.Dr.(b)(6) continued to engage the undesirable intravascular material (uim) while observing progress under tee.Echo confirmed there was about a 20% reduction in the uim and no significant changes with continued engagement of the av.Dr.(b)(6) pulled back the av to the svc / ra junction and flows were increased to 4.0l and the uim was re-engaged with the av cannula, with echo reporting no change in the size.The av was pulled back and then repositioned distal to the uim.Adjunctive device was utilized to break up the core of the uim and the material embolized.Procedure converted from av to open at this time and the pt.Was put on bypass.The blood was pulled from the circuit into the cell saver to be returned to the pt.At the conclusion of his open procedure.The used device was discarded at the hospital.

• Brand Name: ANGIODYNAMICS / ANGIOVAC
• Type of Device: CATHETER, CANNULA & TUBING, VASCULAR
• Manufacturer (Section D): ANGIODYNAMICS; 26 forest street; marlborough MA 01752
• 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: 6148999
• MDR Text Key: 61551625
• Report Number: 2952363-2016-00013
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: H965251860
• UDI-Public: H965251860
• 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
• Report Date: 11/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: H965251860
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/08/2016
• Initial Date FDA Received: 12/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention
• Patient Age: 38 YR