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

Model Number C11165

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Necrosis (1971); Unspecified Tissue Injury (4559)

Event Date 10/17/2022

Event Type  Death  

Event Description

During the atrial fibrillation procedure the patient suffered a pressure wound created by the femostop which led to sepsis and ultimately death.The femostop is estimated to have been in use for 10-14 hours.7 days after the procedure the patient had a groin bleed and the area of the wound became necrotic requiring a skin graft.The patient expired 3 weeks after the procedure.There is no further information.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.The ifu states: "warning: do not leave the system on the patient for inappropriately long compressions, as tissue damage may be produced.A brief interruption at least every three hours of pressure is recommended during long compression periods.Inappropriately long compression and/or immobilization may increase the risk for thrombosis or embolization which could lead to patient injury or death." the device history records for each possible batch number (8438660 or 8568271) were reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined.

Manufacturer Narrative

Corrected information: h2, h6.

• Brand Name: FEMOSTOP GOLD
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 15797558
• MDR Text Key: 303642996
• Report Number: 2648612-2022-00011
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110193
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C11165
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Death