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

Model Number 5140-5131

Device Problem Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/02/2021

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided.Cardiacassist inc.Manufactures the protek duo veno-venous cannula.Lot number was not available from customer.The problem occured the same day of the cannulation.The device was fixed following the dfu.As per medical assessment the cannula migration is an event which can cause death or serious injury.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 a report about a cannula migrated from pa to rv.No patient impact reported.

Manufacturer Narrative

H.10: the serial number of the device remains unknown despite requested thus no dhr analysis could be conducted.The cannula was discarded by the customer and was not made available for investigation thus no product analysis could be performed.No cannula visible defect was reported by the customer facility.Based on available information and investigation of previous similar cases, cannula migration is not related to any device specific malfunction and may depend on external factors such as patient movements and/or accidental manipulation of the device by the users and/or cannula not properly secured to the patient.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

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 PA 15238
• Manufacturer (Section G): CARDIACASSIST INC.; 620 alpha drive; pittsburgh PA 15238
• Manufacturer Contact: enrico greco ; 620 alpha drive; pittsburgh, PA 15238
• MDR Report Key: 13109500
• MDR Text Key: 287556152
• Report Number: 2531527-2021-00053
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/02/2021

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 Model Number: 5140-5131
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/02/2021
• Initial Date FDA Received: 12/29/2021
• Supplement Dates Manufacturer Received: 02/02/2022
• Supplement Dates FDA Received: 03/01/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1