MAUDE Adverse Event Report: CARDIACASSIST INC. PROTEK SOLO FEMORAL ARTERIAL CANNULA; FEMORAL ATERIAL CANNULA

Model Number 5130-1717

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

Patient Problem Hemolysis (1886)

Event Date 05/21/2018

Event Type  Injury  

Event Description

Information was received indicated that the patient was bleeding from the right femoral artery after removal of the tandem heart device.Surgical repair of the right femoral artery was done in the operating room.No non-conformances or deviations found in the dhr for the cannula.

Event Description

The device manufacturer date and expiration date were added.No additional or relevant information has been received to date.

Manufacturer Narrative

Additional device information, expiration date, corrected data: initial mdr inadvertently did not report device manufacturer date.Device manufacturer date, corrected data: initial mdr inadvertently did not report device manufacturer date.

• Brand Name: PROTEK SOLO FEMORAL ARTERIAL CANNULA
• Type of Device: FEMORAL ATERIAL CANNULA
• Manufacturer (Section D): CARDIACASSIST INC.; 640 alpha drive; pittsburgh PA 15238
• MDR Report Key: 8299110
• MDR Text Key: 134844643
• Report Number: 2531527-2019-00017
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• PMA/PMN Number: K120543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/18/2019

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 Expiration Date: 03/18/2018
• Device Model Number: 5130-1717
• Device Catalogue Number: 5130-1717
• Device Lot Number: AMO62871
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/04/2019
• Initial Date FDA Received: 02/01/2019
• Supplement Dates Manufacturer Received: 09/18/2019
• Supplement Dates FDA Received: 09/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention