MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. FEMOSTOP GOLD; CLAMP, VASCULAR

Model Number GOLD

Device Problem Protective Measures Problem (3015)

Patient Problem Insufficient Information (4580)

Event Date 10/11/2021

Event Type  malfunction  

Event Description

When utilizing the device, to discontinue femoral arterial line, staff noticed error reading e05 on the display and no numbers when device was inflated.A second package was opened with same issues.A third package was opened and worked properly.All packages had the same lot number.

• Brand Name: FEMOSTOP GOLD
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 12933003
• MDR Text Key: 281738304
• Report Number: 12933003
• Device Sequence Number: 1
• Product Code: DXC
• 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: 12/01/2021

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 Model Number: GOLD
• Device Catalogue Number: C11165
• Device Lot Number: 7907926
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/01/2021
• Date Report to Manufacturer: 12/06/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27363 DA