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

Catalog Number VTX-3022

Device Problem Occlusion Within Device (1423)

Patient Problem Pulmonary Embolism (1498)

Event Date 03/21/2014

Event Type  Injury  

Event Description

With an 18f return arterial cannula placed in the right femoral sheath, the angiovac cannula was place in the right ij sheath over an 0.035 guidewire.Flow rates were initiated to 3 liters per min.When the flow rates dropped to zero, a ct image confirmed that a large undesirable intravascular material (uim) was occluding the cannula.The cannula was removed and a large uim was attached to the tip of the cannula.The cannula and the sheath were flushed and then re-introduced with flow rates of 3 liters achieved.Approximately 5-10 minutes after re-introduction of the cannula, the patient became hemodynamically unstable and cpr was initiated.The patient was put on ecmo support.A pa-gram was performed and revealed a pulmonary embolism in the rpa lower lobe.The patient was removed off ecmo on (b)(6) 2014 and a brain scan performed.She is recovering and has no adverse outcomes in regards to the angiovac procedure or cpr.No malfunction of the angiovac cannula or circuit was observed at any time by the clinical specialist or physician.The device is being retained by the hospital.

Manufacturer Narrative

Although it is not believed that the cause of the reported event is related to device malfunction, the investigation into this event is on-going, and will be including a review of the device history records for the reported lot.Upon completion of the investigation, a supplemental medwatch will be submitted.(b)(4).

Manufacturer Narrative

This medwatch was originally submitted under manufacturer report number: 3008075679-2014-00002.The manufacturer name has since changed from vortex medical to angiodynamics, and the manufacturer site registration number from 3008075679 to 2952363.The purpose of this supplemental form is to update the manufacturer report number from 3008075679-2014-00002 to 2952363-2014-00005.

Manufacturer Narrative

A review of the device history records was performed for the reported packaging lot for any deviations related to the reported defect of the complaint.The review confirms that the lot met all material, assembly and performance specifications.A review of the angiodynamics complaint report for the angiovac product family and the failure mode "patient injury" did not reveal any adverse trends.The end user hospital confirmed that there was no angiovac device malfunction during the procedure - device was not returned for evaluation.The patient's serious adverse event was related to anticipated procedural complications for removal of uim and the patient's medical condition.The angiovac cannula component is supplied to angiodynamics by the supplier duke emperical.Duke was been notified via supplier corrective action request for a device history records review of the supplier lot.Their response indicated that the od of the cannulas for the units released all meet the specification.All manufacturing records were completed and in order.There were no abnormalities that could have contributed to the reported event.The angiovac cannula sample was not returned for evaluation since there was no reported device failure.It cannot be determined if the cannula was used in accordance with its labeling.Directions for use are provided with this device and contains the following statements: adverse affects: 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 damage and complications of percutaneous or surgical insertion techniques.These may occur if the instructions for use are not followed." (b)(4).Not returned to manufacturer.

• Brand Name: ANGIOVAC
• Type of Device: CATHETER, CANNULA & TUBING, VASCULAR
• 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: 3918076
• MDR Text Key: 4584477
• Report Number: 2952363-2014-00005
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092486
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: VTX-3022
• Device Lot Number: 106711-1
• Other Device ID Number: ANGIOVAC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/21/2014
• Was Device Evaluated by Manufacturer?: No
• 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): Life Threatening; Required Intervention
• Patient Age: 51 YR
• Patient Sex: Female