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

Catalog Number 201-50055

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 07/14/2015

Event Type  malfunction  

Manufacturer Narrative

Device unique identifier (udi) ¿ device was manufactured prior to the udi labeling implementation.The device is expected to be returned.It has not yet been received.The event occurred at (b)(6).No further information is available at this time.A supplemental report will be submitted when the manufacturer's investigation is completed.

Event Description

It was reported that the patient required left ventricular extracorporeal circulatory support.During insertion of the drainage cannula, while it was being pulled through the chest wall, it was noticed that the blue shrink seal at the distal end of the cannula was missing.After a brief search of the chest cavity, the blue shrink seal was found and placed back onto the cannula close to the original position.The patient did not suffer any adverse effects and the operation was concluded without further incident.No additional information was provided.

Manufacturer Narrative

The end of the drainage cannula was cut off at the hospital and was returned for investigation.Additionally, a photo of the cannula and blue shrink seal was received.The evaluation confirmed that the blue shrink seal was loosened and was not fitted to the cannula pvc material.A review of the device history records found no deviations from manufacturing or quality assurance specifications.The reported event of the dislodged blue shrink seal is being addressed through the corrective and preventive action process.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG 34F DRAINAGE CANNULA
• Type of Device: CANNULA
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CA CH-80 05; SW CH-8005
• 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: 5021718
• MDR Text Key: 23744093
• Report Number: 2916596-2015-01535
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 07/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2016
• Device Catalogue Number: 201-50055
• Device Lot Number: 2014071050
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2014
• 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