MAUDE Adverse Event Report: MEDTRONIC, INC. MEDTRONIC DLP 24 FR METAL RIGHT ANGLE VENOUS CANNULA ; CATHETER, CANNULA AND TUBING VASCULAR, CARDIOPULMONARY BYPASS

Model Number 24FR SINGLE STAGE VENOUS CANNULA

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/10/2020

Event Type  malfunction  

Event Description

Upon decannulation of the ivc, it was noted that the 24 fr right angle cannula used contained clot.Fda safety report id# (b)(4).

• Brand Name: MEDTRONIC DLP 24 FR METAL RIGHT ANGLE VENOUS CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MEDTRONIC, INC. ; minneapolis MN 55432
• MDR Report Key: 9720839
• MDR Text Key: 180043415
• Report Number: MW5093030
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/12/2020

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 Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: 24FR SINGLE STAGE VENOUS CANNULA
• Device Catalogue Number: 69324
• Device Lot Number: 2019110840
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/14/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 29 YR
• Patient Weight: 26