MAUDE Adverse Event Report: THORATEC CORPORATION PARACORPOREAL VENTRCULAR ASSIST DEVICE; VENTRICULAR ASSIST DEVICE

Catalog Number 14086-2550-000

Device Problems Leak/Splash (1354); Cut In Material (2454)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/17/2015

Event Type  malfunction  

Manufacturer Narrative

Device unique identifier (udi) - device was manufactured prior to udi labeling implementation.Approximate age of device - 1 year and 3 months.The device was returned for investigation.The evaluation is not yet complete.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

The patient was implanted with biventricular paracorporeal ventricular assist devices.It was reported that the patient presented to the vad clinic with what appeared to be a break or cut in the right ventricle pump's pneumatic driveline.The cut was reportedly located on the first segment of the tubing originating from the pump body just prior to the metal y-connector bifurcation.The cut was approximately 3 millimeters in length and ran perpendicular to the tubing pathway.It was reported that some air was leaking out with every ejection; however, the patient was not symptomatic and there were no alarms at the time.The site was temporarily stabilized and the patient was taken to the operating room.The patient was administered a small dose of fentanyl, and the pump was exchanged.The new pump reportedly initiated successfully and the patient was discharged home later that day in stable condition.

Manufacturer Narrative

Damage to the braided tubing was confirmed through the evaluation of the returned device; however, a specific cause for the formation of the observed crack could not conclusively be determined.The pump returned with tape applied on to the pneumatic lead near the y connector.Removal of the tape revealed a crack in the pneumatic lead.Further examination revealed that the crack had penetrated both layers of the braided tubing, affecting the ability of the braided tube to hold air.Based on the manufacturer''s past experienced from similar reported events, the observed crack likely resulted from the articulation of the braided tubing and/or orientating the braided tubing at an angle during support, causing failure by fatigue.A review of the device history records revealed no deviations from manufacturing or quality assurance specifications.The manufacturer is closing the file on this event.

• Brand Name: PARACORPOREAL VENTRCULAR ASSIST DEVICE
• Type of Device: VENTRICULAR ASSIST DEVICE
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: robert fryc ; 23 fourth avenue; burlington, MA 01803 ; 781272-013
• MDR Report Key: 5155189
• MDR Text Key: 28439919
• Report Number: 2916596-2015-01916
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Followup
• Report Date: 09/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Catalogue Number: 14086-2550-000
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 92