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

Model Number 5140-3631

Device Problem Migration (4003)

Patient Problems Death (1802); Cardiac Tamponade (2226)

Event Date 08/29/2020

Event Type  Death  

Manufacturer Narrative

Cardiacassist inc.Manufactures the protek duo veno-venous cannula.The incident occurred in (b)(6).Livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova received report of a potential right ventricular perforation after a patient supported by the protekduo.Reportedly the patient was awake and moving with reduced sedation.Flows dropped acutely to 0.0lpm, and differential diagnosis of potential cannulae/anatomic clot was investigated.The system was stopped, clamped; sidewall of tubing was punctured and wired, protekduo31 rd was removed over the wire, and another protekduo31 rd was placed with a new tandemheart and tandemlung circuit.The patient only briefly resumed flows, with concern for cardiac tamponade, a pericardiocentesis was urgently performed to produce serial and copius dark blood.Ongoing hemodynamic instability and hypoxemia could not be controlled and the patient was declared.The surgeon suspected that the cannulae was appropriately placed initially, but may have migrated proximally with the patient movement and deep coughs when it thereafter crossed the tricuspid valve, and entered the right ventricle, ultimately penetrating the apical free wall.

Manufacturer Narrative

Based on the available information, surgeon suspected that cannula may have migrated due to patient movement and deep coughs, crossing the tricuspid valve and entering the right ventricle.Serial number of the involved cannula is unknown; however review of dhr related to last seven protekduo rd cannulae shipped to the involved facility (lots 238377, 220300, and 216073) did not identify any deviations or non-conformities relevant to the reported issue.Based on the above, most likely root cause of the reported event can be: - cannula deformation and migration due to patient movements and/or - cannula not correctly secured to the patient.

• 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 15238
• MDR Report Key: 10599542
• MDR Text Key: 208947744
• Report Number: 2531527-2020-00031
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• PMA/PMN Number: K160257
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/28/2020

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 Model Number: 5140-3631
• Device Catalogue Number: 5140-3631
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/31/2020
• Initial Date FDA Received: 09/29/2020
• Supplement Dates Manufacturer Received: 10/31/2020
• Supplement Dates FDA Received: 11/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death