MAUDE Adverse Event Report: MEDTRONIC, INC. BIO-MEDICUS; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number 96600-125

Device Problems Failure to Advance (2524); Physical Resistance/Sticking (4012)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/07/2023

Event Type  malfunction  

Event Description

The wire was in patient.The md tried to thread the cannula over the wire and could not advance it.Had a problem removing the dilator also.It was stuck.Had to pull the entire cannula, dilator and wire out of the patient and open a new kit and start over.Manufacturer response for venous femoral cannula, bio-medicus (per site reporter).Unknown at this time.

• Brand Name: BIO-MEDICUS
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MEDTRONIC, INC.; 4340 swinnea road; bldg. b; memphis TN 38118
• MDR Report Key: 16333961
• MDR Text Key: 309141380
• Report Number: 16333961
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/07/2023

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 Model Number: 96600-125
• Device Catalogue Number: 96600-125
• Device Lot Number: 225112488
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/07/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/09/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/09/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24090 DA
• Patient Sex: Female
• Patient Race: White