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

Model Number 5140-5131

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Perforation (2513)

Event Date 09/08/2020

Event Type  Injury  

Manufacturer Narrative

There was no patient involvement.Cardiacassist inc.Manufactures the protek duo cannula.The incident occurred in (b)(6).A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova received a report that during protek duo cannula insertion, a perforation of the right ventricle (rv) occurred.The rv was repaired and the patient was cannulated with another cannula for vv support.The patient is currently stable.

Manufacturer Narrative

H.10: patient was affected by covid-19.Serial number of the involved device is unknown.However, review of dhr related to last ten 31 fr protekduo cannulae shipped to the involved facility (lots 244342, 257707, and 260402) did not identify any deviations or nonconformities relevant to the reported issue.Based on the above, it cannot be ruled out that reported event was due to user technique in advancing the cannula into patient.

Event Description

See initial 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 15238
• MDR Report Key: 10655164
• MDR Text Key: 210600621
• Report Number: 2531527-2020-00032
• 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: 10/06/2020

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: 5140-5131
• Device Catalogue Number: 5140-5131
• Device Lot Number: UNKNOWN
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/09/2020
• Initial Date FDA Received: 10/09/2020
• Supplement Dates Manufacturer Received: 11/03/2020
• Supplement Dates FDA Received: 12/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other