MAUDE Adverse Event Report: CARDIACASSIST INC. PROTEK DUO VENO-VENOUS CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Catalog Number 5140-4629

Device Problem Insufficient Information (3190)

Patient Problem Pneumothorax (2012)

Event Date 02/12/2021

Event Type  Injury  

Manufacturer Narrative

Device lot number was not provided, so udi and expiration date could not be determined.As lot number is unknown, manufacture date could not be determined.Livanova manufactures the protekduo 29fr cannula.The reported event occurred in (b)(6).The report from the customer indicated that the cannula placement looked good post-cannulation.Patient suffered from covid-19, which can lead to pneumothorax.No specific device malfunction was reported in the initial report.If any additional information relevant to the reported event is received, it will be provided in a supplemental report.H3 other text : device not available for return.

Event Description

Livanova received a report through the theme clinical study that a patient experienced right tension pneumothorax following cannulation with a protekduo 29fr cannula.A chest tube was placed immediately and a ct scan confirmed resolution of the pneumothorax.

Manufacturer Narrative

A clinical evaluation was performed which noted that this event was unlikely directly attributable to the cannula specifically, and would likely be associated with the therapy (vv ecmo with rij cannulation).As the patient suffered from covid and the event occurred more than 18 months prior to being reported to livanova, the device was not made available for return.However, it is known that covid-19 disease can contribute/lead to therapy complications including pneumothorax.The report from the customer indicated that the cannula placement looked good post-cannulation and no specific allegation of malfunction was made against the device.Based on all available information, the reported issue is most likely not device related and instead associated to patient condition and therapy.The serial/lot number of the device was not provided, so a review of the dhr could not be completed.Taking into account all the above facts, the most likely root cause of the reported event is patient-related and a device malfunction can be excluded.This event was most likely associated with the therapy itself (vv ecmo with rij cannulation).As no device malfunction could be determined, specific corrective actions were not identified.If any additional information relevant to the reported event is received, it will be provided in a supplemental report.

• Brand Name: PROTEK DUO VENO-VENOUS CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): CARDIACASSIST INC.; 620 alpha drive; pittsburgh PA
• Manufacturer (Section G): CARDIACASSIST INC.; 620 alpha drive; pittsburgh PA 15238
• Manufacturer Contact: ryan coyle ; 620 alpha drive; pittsburgh, PA 15238
• MDR Report Key: 15790645
• MDR Text Key: 303582308
• Report Number: 2531527-2022-00050
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160257
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/13/2023

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 Catalogue Number: 5140-4629
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/05/2022
• Initial Date FDA Received: 11/14/2022
• Supplement Dates Manufacturer Received: 01/27/2023
• Supplement Dates FDA Received: 02/13/2023
• 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): Other