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

Device Problems Defective Device (2588); Protective Measures Problem (3015)

Patient Problem Insufficient Information (4580)

Event Date 02/28/2022

Event Type  malfunction  

Event Description

New fem stop placed 1st one not working.Multiple fem stops placed.Two (2) of the femostop had eo5 code and was not working; 4th femostop finally placed and working.

• Brand Name: FEMOSTOP
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): ST. JUDE MEDICAL
• MDR Report Key: 13938726
• MDR Text Key: 288197116
• Report Number: MW5108576
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/25/2022
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American