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

Catalog Number VTX-3022

Device Problems Inflation Problem (1310); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Perforation (2001); Cardiac Perforation (2513)

Event Date 07/05/2015

Event Type  Injury  

Event Description

A pulmonary embolectomy was performed on (b)(6) 2015 using an angiovac.There was a clot removed from the patient but the patient's pressure kept dropping.One liter of blood was removed from the pericardial sac.Pressure improved significantly, and the case continued.About 30 min.Later, dr.(b)(6) decided to stop the case.The patient then went in for a sternotomy and they discovered that there was a perforation of the rvot (right ventricular outflow tract) and a tear in the chordae tendineae of the tricuspid valve (the surgeons found the small tear on the outflow tract, but deemed it unnecessary to repair).The patient survived and was put on ecmo.She came off ecmo (b)(6) 2015.Two angiovac cannulas were used during the procedure.The first cannula had a problem with the balloon failing to remain inflated.It was replaced, and the case continued without further incident relating to the cannula.The used the device was discarded at the hospital.

Manufacturer Narrative

Although no sample will be returned for evaluation, the investigation into this event is on-going.Upon completion of the investigation, a supplemental medwatch will be submitted.(b)(4).

Manufacturer Narrative

The end user hospital did not report a lot number for item vtx-3022 for the reported event.Based on the attached ship history report (shr) obtained from (b)(4), there were only two lots (107221 & 107286) the customer received within the six months prior to the reported procedure date of (b)(6) 2015.The device history records for these lots were reviewed.The dhr reviews revealed no abnormalities or non-conformances at the time of manufacture.The angiodynamics complaint report was reviewed for the f angiovac product family and the failure mode "patient injury/death." no adverse trend was indicated.The angiovac cannula sample was not returned for evaluation since there was no reported device failure.Therefore, 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: "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." the root cause for the reported event is unable to be determined, however there were no reports of angiovac malfunction or performance issues during the procedure.(b)(4).Device not returned to manufacturer.

• Brand Name: ANGIOVAC
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR
• 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: 4929238
• MDR Text Key: 6008792
• Report Number: 2952363-2015-00008
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133445
• 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: 07/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: VTX-3022
• Other Device ID Number: ANGIOVAC CANNULA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/05/2015
• 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; Life Threatening; Required Intervention