MAUDE Adverse Event Report: MEDTRONIC PERFUSION SYSTEMS MEDTRONIC DLP 20 FR RIGHT ANGLE VENOUS CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number 20 FR SINGLE STAGE VENOUS CANNUL

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problem Insufficient Information (4580)

Event Date 12/15/2020

Event Type  malfunction  

Event Description

Upon decannulation of the innominate vein it was noted that the 20 fr right angle cannula used contained clot.Fda safety report id # (b)(4).

• Brand Name: MEDTRONIC DLP 20 FR RIGHT ANGLE VENOUS CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MEDTRONIC PERFUSION SYSTEMS ; minneapolis MN 55432
• MDR Report Key: 11036724
• MDR Text Key: 241258455
• Report Number: MW5098440
• Device Sequence Number: 1
• Product Code: DWF
• 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: 12/16/2020

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: 04/30/2023
• Device Model Number: 20 FR SINGLE STAGE VENOUS CANNUL
• Device Catalogue Number: 69320
• Device Lot Number: 2020040500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/17/2020
• 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: 28 YR
• Patient Weight: 55