MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. FAST-CATH; INTRODUCER, CATHETER

Model Number 406137

Device Problem Disconnection (1171)

Patient Problem Insufficient Information (4580)

Event Date 02/15/2021

Event Type  malfunction  

Event Description

Patient had moved in bed and the sideport of the swan-ganz catheter had disconnected and popped off.However, there has been recurring issues with this lot of devices.

• Brand Name: FAST-CATH
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 14901 deveau pl.; minnetonka MN 55345
• MDR Report Key: 11364855
• MDR Text Key: 233047821
• Report Number: 11364855
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 406137
• Device Catalogue Number: 406137
• Device Lot Number: 7642611
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/17/2021
• Event Location: Hospital
• Date Report to Manufacturer: 02/23/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 25185 DA
• Patient Weight: 26