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

Catalog Number H965251860

Device Problems Occlusion Within Device (1423); Insufficient Flow or Under Infusion (2182)

Patient Problems Pulmonary Embolism (1498); Death (1802); Hemorrhage, Cerebral (1889); Low Oxygen Saturation (2477)

Event Date 04/24/2015

Event Type  Death  

Event Description

As reported by the clinical specialist: "the angiovac cannula was inserted and then had to be removed several times due to clotting and low flow rates.We were never able to achieve optimal flow rates and had to switch cannulas.At the end of the case the pt's oxygen saturation began to drop, which dr (b)(6) suspected was caused by a pulmonary embolism.The pt was admitted to the unit for overnight observation.The pt expired the next day due to pulmonary embolism and cerebral hemorrhage." the used cannula will be returned for eval.

Manufacturer Narrative

It has been indicated that the used device is being returned to angiodynamics; however, it has not yet arrived.Upon completion of the investigation, a supplemental medwatch will be submitted.(b)(4).

Manufacturer Narrative

The reported packaging lot 4862961 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, duke empirical, 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 trends were identified.Based on the evaluation of the returned angiovac cannula 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, hemorrhage, pulmonary embolism." as received, the device was contaminated with bio matter.The balloon sheath was on the cannula, covering the distal portion of the white strain relief.No obvious damage or manufacturing defects were noted.During the disinfection process, it was noted that the inflation line was occluded and could not be flushed with fluid due to dried contrast in the lumen from the procedure.A heise air pressure station was connected to the inflation lumen tubing via the female fitting - pressure was set to 14.7 psi (~1.0 atm); no pressure decay noted.The balloon could not be inflated, due to the inflation line occlusion.A 0.014" guidewire was fed into the inflation line through the stopcock.The guidewire was inserted through approximately 1/3 of the cannula tubing when the guidewire hit the occlusion.The end user's reported complaint description of low flow rates (i.E.Potential balloon inflation issues) could not be confirmed due to the condition the sample was received in; sample was occluded with dried contrast.Performance of inner balloon could not be evaluated.The root cause of the patient death is attributed to pulmonary embolism and cerebral hemorrhage and is not related to the performance of the angiovac cannula.(b)(4).

• Brand Name: ANGIODYNAMICS/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: 4795698
• MDR Text Key: 17580228
• Report Number: 2952363-2015-00005
• 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: 04/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Catalogue Number: H965251860
• Device Lot Number: 4862961
• Other Device ID Number: ANGIOVAC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2015
• 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
• Patient Age: 66 YR