MAUDE Adverse Event Report: MEDTRONIC, INC. MEDTRONIC DLP 22 FR RIGHT ANGLE VENOUS CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number 22 FR RIGHT ANGLE VENOUS CANNULA

Device Problem Coagulation in Device or Device Ingredient (1096)

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

Event Date 10/28/2020

Event Type  malfunction  

Event Description

Upon decannulation of the svc, it was noted that the 22 fr right angle cannula used contained clot.Fda safety report id # (b)(4).

• Brand Name: MEDTRONIC DLP 22 FR 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: 11036496
• MDR Text Key: 222637671
• Report Number: MW5098429
• 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: 12/15/2020

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: 22 FR RIGHT ANGLE VENOUS CANNULA
• Device Catalogue Number: 69322
• Device Lot Number: 2020040155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2020
• 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: 32 YR
• Patient Weight: 88