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

Catalog Number 201-50055

Device Problem Break (1069)

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

Event Date 01/03/2018

Event Type  malfunction  

Manufacturer Narrative

The patient''s age, gender and weight were not provided.(b)(4).Approximate age of device ¿ day of implant.The device is expected to be returned for analysis.It has not yet been received.The event occurred at queen elizabeth hospital, uk.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

The patient required an extracorporeal circulatory support device for biventricular support.It was reported that during the procedure, there was difficulty inserting the cannula through the chest wall; at this point, a wire was observed protruding through the polyurethane at the tip of the drainage cannula.It was reported that the patient did not suffer any adverse effects.No additional information was provided.

Manufacturer Narrative

The evaluation of the returned centrimag 34fr drainage cannula confirmed the report that the stabilization wire had protruded through the plastic material at the proximal end of the cannula; however, a specific cause for this finding could not conclusively be determined.Certificates of compliance from each outside contractor (j-pac medical and avalon laboratories) were reviewed and no deviations were identified.Additionally, an investigation report was provided by j-pac indicating that nothing unusual or indicative of an issue was noted upon review of the design history records (dhr) for this cannula's lot.According to the records, product was correctly built.J-pac concluded that the cannula could have been subjected to a severe bend or had been bent multiple times at the extreme end of the assembly, causing the wire to tear loose from the plastic over-mold and break away from the core assembly.The functionality of the stabilization wire is defined in the centrimag 34fr drainage (venous) cannula kit instructions for use (ifu).Depending on the applied technique by the surgeon and the position of the resting patient, it may be necessary to bend the tip of the cannula.The wire stabilizes the cannula in its bent form and supports a proper attachment of the cannula to a blood vessel.The ifu does not define the maximally allowed bending angle or the number of times it can be bent.Of note, however, the bending of the cannula tip is done in the preparation phase before its application.Additionally, the ifu warns the user to always have a spare centrimag drainage (venous) cannula available for exchange.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 CH-80 05; SZ CH-8005
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; technoparkstrasse 1; pleasanton CA 94588
• Manufacturer Contact: bob fryc ; 6101 stoneridge dr.; pleasanton, CA 94588 ; 7818528390
• MDR Report Key: 7236486
• MDR Text Key: 99081173
• Report Number: 2916596-2018-00417
• 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: Initial,Followup
• Report Date: 06/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: 201-50055
• Device Lot Number: 2017012023
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/11/2018
• Initial Date FDA Received: 02/02/2018
• Supplement Dates Manufacturer Received: 05/29/2018
• Supplement Dates FDA Received: 06/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2017
• 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