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

Catalog Number H965251860

Device Problem Insufficient Information (3190)

Patient Problem Pericardial Effusion (3271)

Event Date 10/30/2018

Event Type  Injury  

Manufacturer Narrative

Although the device from the reported event is not available to be returned to angiodynamics, the investigation into this event is on-going, involving a review of the manufacturing records as well as the request of additional information from clinical specialists.Upon completion of the investigation, a supplemental medwatch will be submitted.((b)(4)).

Event Description

Event description as provided by angiodynamics' medical "liason": (b)(6) african american female with history of obesity, (b)(6), and esrd presented with large mobile right atrial mass extending from the superior vena cava to the tricuspid valve.Tricuspid valve does not appear to be involved.Mass suspected to be a fibrin sheath from previous dialysis catheter.Physician stated internal "jugluars" are not accessible.Patient is s/p dialysis catheter placement in the right femoral vein.Patient was brought into the operating suite and placed supine on the procedure table.Patient was intubated and transesophageal echo performed confirming large mobile mass present.Patient's full chest and abdomen were prepped and drapes applied in a sterile fashion.Fluoroscopy imaging will not be utilized per physician's orders.The angiovac circuit was assembled and primed per ifu.The angiovac was prepped and primed per ifu.The balloon tip was lubricated with sterile gel.The angiovac was placed over the amplatz ss 260cm wire into the 26fr gore dryseal in the right femoral vein.The angiovac was advanced over the amplatz ss curve tip 260cm wire to the level of the ivc/ra junction.The dilator and wire were removed.Angiovac balloon was inflated to 1.5atms.Fluoroscopy confirmation of balloon expansion was not available.The physician ordered the perfusion team to start the "centrifical" pump.3 liters of flow confirmed.The angiovac was advanced to the ra/svc junction.Flow rates dropped to 0.5 liters per minute.Material was engaged as confirmed by transesophageal echo.The physician ordered the perfusion team to increase the rpm's.Angiovac left in place for approximately 1 minute, then, slowly retracted from the svc/ra junction to the caval atrial space.Small amount of material visualized in the angiovac circuit.Transesophageal echo revealed mass still present.Anesthesia stated the patient was "not doing well".A large cardiac effusion was visualized on the transesophageal echo.Vital signs were core temp 36.3, etco2 24, heart rate 134, o2 sat 40%, mean arterial pressure 56.Angiovac cannula was removed.Blood was not returned to the patient.The physician elected to perform a pericardial window and place a drain.Patient's vital signs dropped during chest access.Core temp 36.3, etco2 23, o2 unreadable, mean arterial pressure 55.Pericardial window created.Drain placed on suction.Large amount of serosanguineous fluid evacuated.Anesthesia stated the patient's vital signs were improving.Transesophageal echo revealed resolution of cardiac effusion.Chest closed.Femoral access sites repaired and triple lumen dialysis catheter replaced in the right femoral vein.End of procedure patient vial signs o2 sat 100%, etco2 33, hr 80, mean arterial pressure 70.Physician stated he thought the wire caused the effusion, then, changed his mind and thinks the angiovac caused the pericardial effusion.The used angiovac cannula was discarded at the hospital.

Manufacturer Narrative

A review of the device history records (dhr)was performed for the indicated packaging and assembly 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.There have been no previously reported complaints for packaging lot {5370128} or purchased cannula component lots {647155 and 648433} for similar issues.The angiovac cannular component is supplied to angiodynamics by duke empirical.A request for a dhr review was completed and concluded that there were no indications that the reported event would have been caused by a manufacturing defect.The recent angiodynamics complaint report was reviewed for the angiovac product family and the failure mode "patient injury/death." no adverse trend was indicated.There was no reported malfunction of the angiovac device during the procedure.The doctor believed either the guidewire or the angovac cannula was the root cause of the cardiac effusion that occurred during the use of the device in this procedure, however, the patient became unstable prior to the angiovac cannula being placed in the body.The angiovac cannula sample was not returned for evaluation 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.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 exact cause of the reported event is unable to be determined, but is not an unanticipated condition/complication for this procedure.(b)(4).

• Brand Name: ANGIODYNAMICS / ANGIOVAC
• Type of Device: CATHETER, CANNULA & TUBING, VASCULAR CARDIOPULMONARY BYPASS
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 8106288
• MDR Text Key: 128424038
• Report Number: 1317056-2018-00212
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: H965251860
• UDI-Public: H965251860
• Combination Product (y/n): N
• PMA/PMN Number: K142593
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/21/2019

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: 07/31/2020
• Device Catalogue Number: H965251860
• Device Lot Number: 5370128
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/01/2018
• Initial Date FDA Received: 11/27/2018
• Supplement Dates Manufacturer Received: 11/01/2018
• Supplement Dates FDA Received: 03/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 26 YR