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

Model Number N/A

Device Problems Entrapment of Device (1212); Difficult to Remove (1528); Failure to Advance (2524)

Patient Problems Death (1802); Exsanguination (1841); Hemorrhage/Bleeding (1888); Perforation (2001); Great Vessel Perforation (2152)

Event Date 12/10/2015

Event Type  Death  

Manufacturer Narrative

The investigation into this event, including evaluation of the returned device, is on-going.Upon completion of the investigation, a supplemental medwatch will be submitted.(b)(4).

Event Description

As reported, "during angiovac case, the physician attempted to remove the angiovac cannula through the 26f sheath but was unable to get the tip of the cannula to pass through the distal tip of the 26f sheath.Physician had to place a wire down through the cannula in order to maintain access while removing the cannula and 26f sheath together.Upon removal of the sheath and cannula, it was noted that the outmost membrane of the tip of the cannula had some blood trapped between it and the balloon/petals, therefore preventing the cannula from being pulled completely through the sheath." after initial cannula/sheath was removed, a new cannula sheath was used.Pressure was placed on the site for about 15 minutes, after which time, the abdomen was opened because of abdominal bleeding.Per the physician, the patient death was attributed to ivc perforation, which occurred during the initial insertion of the cannula and obturator through the sheath.The used device has been returned to angiodynamics for evaluation.

Manufacturer Narrative

The reported packaging lot 4943462 for angiovac cannula item # h965251850 had a purchased angiovac cannula component item (lots 592811, 594308; 601214) packaged in it.A review of the device history records was performed by (b)(4) (supplier) 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 indicated.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, damage to vessel, pulmonary embolism, ventricular perforation." the returned cannula device was stuck in the sheath since the tip/outer membrane was filled with blood.The cannula was removed from the sheath and cleaned.The tip of the cannula/outer membrane could not be visualized due to the dried blood inside of the outer membrane.The distal portion of the outer membrane where it attaches to the petals was cut around the circumference of the tip; this allowed the outer membrane to be peeled back for thorough cleaning of the device.Visual inspection of the outer membrane after this cleaning process showed, a hole/slice in the middle of the outer membrane.The jagged nature of this damage indicates it was likely a result of a puncture.There was no other damage observed on the device and no manufacturing related defects observed.The end user's reported complaint description of not being able to withdraw the cannula tip back through the sheath was confirmed based on sample evaluation.The root cause of this was the outer membrane being damaged (hole/slice in membrane) which allowed blood to collect inside of the outer membrane.This created a blood filled "balloon" whose diameter was larger than the sheath id, thus not being able to be pulled through the sheath.The root cause of what puncture the outer membrane could not be determined but event details state patient had ivc filter so this is potential source of the puncture damage.The potential root cause for the vessel perforation is from the obturator of the angiovac cannula during the initial placement.The sheath came back, so dr.(b)(6) tried to advance the cannula/obturator.In discussion a few days after the case, the physician admitted to angiodynamics sales/clinical personnel that he should have used a guidewire for placement.No autopsy was performed on the patient, so there is no clinical proof of his assumption.(b)(4).

• 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: 5366319
• MDR Text Key: 35973066
• Report Number: 2952363-2016-00001
• 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: 12/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Model Number: N/A
• Device Catalogue Number: H965251850
• Device Lot Number: 4943462
• Other Device ID Number: ANGIOVAC
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/21/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2015
• 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