MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH THORATEC CENTRIMAG DRAINAGE CANNULA KIT; DWA: DRAINAGE CANNULA KIT

Model Number 201-50067

Device Problems Break (1069); Hole In Material (1293)

Patient Problems Air Embolism (1697); Respiratory Distress (2045)

Event Date 12/05/2013

Event Type  Injury  

Event Description

The pt was implanted with a ventricular assist device (vad) for acute support.The patient was in the hospital on bivad support.The vad coordinator reported that the patient's pump cannula wires broke and eroded into the blood path causing air entrainment into the pump circuit.The pt experienced shortness of breath and was desaturated.An oxygenator was placed into pump circuit to support the patient.The cannula was splinted and taped and multiple actions were taken to prevent the air entrainment.The patient had been extremely active and was ambulating, but then had to remain immobile in bed awaiting a heart transplant.The pt also pointed out another break in the drainage cannula wire.The patient was transplanted on (b)(6) 2014.

Manufacturer Narrative

The pt was transplanted.No further info is available at this time.A supplemental report will be submitted when the device analysis is completed.

Manufacturer Narrative

The drainage cannula remained in use until the patient was transplanted, and was not returned for analysis.The report of a break in the wire within the drainage cannula was confirmed based on the images submitted at the time of the event.Use of the device was intended as a bridge to transplant.The centrimag drainage cannula is intended to be used as a venous drainage cannula in an extracorporeal bypass circuit for extracorporeal circulatory support for periods up to six hours.No further information is available.The manufacturer is closing its file on this event.

• Brand Name: THORATEC CENTRIMAG DRAINAGE CANNULA KIT
• Type of Device: DWA: DRAINAGE CANNULA KIT
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; zurich ; SZ
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: robert fryc ; 23 fourth avenue; burlington, MA 01803 ; 7812720139
• MDR Report Key: 3591364
• MDR Text Key: 4035949
• Report Number: 2916596-2014-00025
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/18/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 201-50067
• Device Catalogue Number: 20150067
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/05/2013
• Event Location: Hospital
• Date Report to Manufacturer: 12/18/2013
• Date Manufacturer Received: 03/20/2015
• 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): Required Intervention
• Patient Age: 46 YR
• Patient Weight: 76