MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG DRAINAGE (VENOUS) CANNULA KIT; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number 201-50067

Device Problems Mechanical Problem (1384); Material Integrity Problem (2978)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/21/2020

Event Type  malfunction  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

It was reported that patient was in the or for bilateral centrimag placement.The physician assistant noticed the 34 fr drainage cannula intended for left ventricle (lv) apex had a visible wire puncturing the cannula.This cannula was not inserted into the lv apical cuff and was replaced with another.A new 34 fr venous cannula was obtained and inserted with wire reinforcement intact.Product will be returned for analysis.

Event Description

Additional clarification was provided for this event, that the wire did not puncture cannula but rather separated from cannula.

Manufacturer Narrative

Manufacturer's investigation conclusion: analysis of the submitted photographs confirmed the reported issue with the cannula wire.However, a specific cause for the cannula wire damage could not be conclusively determined through this evaluation.The submitted images showed the end of the cannula with a wire that was separated from the cannula body.There was blood present on the tip of the cannula, consistent with the report that the event occurred during implant.A specific cause for the separation of the wire could not be conclusively determined through this evaluation.Multiple requests for additional information, including if the device will be returned, were sent to the customer; however, no response has been received at this time.The reported issue was forwarded to abbott manufacturing for further analysis.The manufacturing analysis (ma) determined that the wire separation issue of the centrimag cannula in question is known design-related failure mode that is identified in failure mode effects and analysis documentation for the cannula and is not related to the manufacturing of the cannula.It was noted that given that this is a design-related failure mode, this failure mode could potentially occur on any cannula in the field; however, it is a known issue per failure mode effects and analysis documentation for the cannula and is not related to the manufacturing process of this specific lot or any lot of the centrimag cannula.A risk assessment was initiated as the manufacturing analysis determined that the wire separation issue of the centrimag cannula in question is a known design-related failure mode.It was determined that no risk action or preventative action needs to be initiated at this time.The centrimag 34fr drainage (venous) cannula kit instructions for use (ifu), rev.11, contains the following information: ¿inspection prior to use¿ contains the following: ¿inspect the outer packaging for any damage, and check the expiration date.Do not use the cannula or any accessories if the package / sterile barrier appear to be compromised, if the cannula has passed its expiration date, or if there is any damage or manufacturing defect.¿ ¿inspection prior to use warnings¿ contains the following: warning #2: "thoroughly inspect the cannula prior to use to verify that the lumen and side holes are patent and that the cannula has not been damaged or kinked." the ifu contains the following warnings and precautions: ifu caution #3: ¿the cannula is supplied sterile.Inspect the device and package carefully prior to use.Do not use if the package or the product has been damaged or soiled.¿ ifu caution #8: ¿always have a spare centrimag drainage (venous) cannula available for exchange.¿ additionally, the centrimag 34fr drainage (venous) cannula kit ifu contains detailed instructions for setup and surgical placement of the cannula.The documentation associated with the centrimag return cannula kit, lot number 2019122100, was reviewed and showed that the lot passed abbott inspection and final lot release.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG DRAINAGE (VENOUS) CANNULA KIT
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• MDR Report Key: 10573118
• MDR Text Key: 208139382
• Report Number: 3003306248-2020-00085
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• PMA/PMN Number: K152190
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/08/2021

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: 12/31/2021
• Device Model Number: 201-50067
• Device Catalogue Number: 201-50067
• Device Lot Number: 2019122100
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/21/2020
• Initial Date FDA Received: 09/23/2020
• Supplement Dates Manufacturer Received: 09/21/2020; 06/30/2021
• Supplement Dates FDA Received: 10/15/2020; 07/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 34 YR
• Patient Weight: 127