MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH THORATEC CENTRIMAG 34F DRAINAGE CANNULA

Catalog Number 201-50067

Device Problems Loss of or Failure to Bond (1068); Fracture (1260); Leak/Splash (1354)

Patient Problem Stroke/CVA (1770)

Event Date 07/19/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4): approximate age of device - 37 days.Information regarding the manufacture date is pending.The patient remains on biventricular extracorporeal support with no further issues reported.No additional information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

It was reported that the patient was on biventricular extracorporeal circulatory support for approximately 37 days when the left ventricle drainage cannula began to leak.The patient had been ambulating when the drainage cannula reportedly cracked circumferentially at the distal connection and it appeared that the adhesive had come loose.The distal portion of the drainage cannula was spliced to a new extracorporeal blood pump circuit.The patient remains ongoing with biventricular support.It was reported that the patient experienced a stroke as a result of the disintegration.Unspecified treatment was rendered for the stroke.No specific information regarding the stroke or any symptoms was provided.

Manufacturer Narrative

The referenced user facility medwatch report is attached.The user facility report number was not provided.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

Additional information was received from a user facility report on (b)(6) 2015 stating: (b)(6) year old male transferred from another facility with cardiogenic shock/respiratory failure on (b)(6) 2015 who was placed on va ecmo, then transitioned to bivad centri-mag with removal of ecmo/iabp on (b)(6).By (b)(6) his condition had improved and bivad explant was planned.At 10:22am rn responded immediately to call by patient's wife who had just removed the patient from the bedpan.The nurse noted a large amount of blood in the sheets and lvad inflow cannula that was disconnected; the tubing was immediately reconnected.Ct fellow at bedside clamped both rvad and lvad outflow.Maps dropped.Lij double central line was inserted and prbcs administered.Lvad team changed the dislodged cannula tubing with resumption of blood flow.Pt.Developed monoclinic movements and head ct was performed which showed hemorrhagic conversation of old pca infarct; likely representing diffuse hypoxic brain injury due to either hypotension or new air emboli.Examination of tubing after the event showed a crack.

Manufacturer Narrative

It was initially reported that the device was not returning for evaluation.The device was subsequently received.Device evaluation: the separation of the drainage cannula from the barbed connector was confirmed through a photograph that was provided by the hospital; however, a root cause for the event could not be conclusively determined through the evaluation.The barbed connector was returned attached to the venous tubing and was secured with a zip tie.The cannulae were not returned.Organic and elemental analysis of the barbed connector were conducted and residue from the pvc cannula was observed over a wide area of the barbed connector, indicating that solvent bonding between the barbed connector and the cannula had occurred.A review of the device history records revealed no deviations from manufacturing or quality assurance specifications.The instructions for use states that the cannula has not been qualified through in vitro, in vivo, or clinical studies for use greater than 6 hours.The patient and family information document lists stroke and major bleeding as potential complications that may be associated with the use of the centrimag system.The documentation also states that any of the complications listed may cause serious injury or death.The manufacturer is closing the file on this event.

• Brand Name: THORATEC CENTRIMAG 34F DRAINAGE CANNULA
• Type of Device: CANNULA
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; 6035 stoneridge drive; zurich ; SZ
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; technoparkstrasse 1; pleasanton CA 94588
• Manufacturer Contact: robert fryc ; 23 fourth avenue; burlington, MA 01803 ; 781272-013
• MDR Report Key: 5023508
• MDR Text Key: 23796763
• Report Number: 2916596-2015-01536
• Device Sequence Number: 1
• Product Code: DWF
• 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: 07/23/2015

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: 09/30/2016
• Device Catalogue Number: 201-50067
• Device Lot Number: 2014091051
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/21/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2014
• 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 Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Weight: 69