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

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

Patient Problem Hemostasis (1895)

Event Date 01/02/2018

Event Type  Injury  

Manufacturer Narrative

The reported event of hematoma could not be confirmed.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.The femostop gold instructions for use (ifu) states that bleeding or hematoma are possible complications from the use of the device.The femostop gold ifu also states that if arterial/venous hemostasis is not achieved, significant bleeding may occur which could result in patient injury or death.The femostop gold ifu states for successful compression, the system must be snug and secure around the patient¿s hips before pressure is applied.Do not over-tighten the belt.The femostop gold ifu states that adequate compression may not be obtained in markedly obese patients.The femostop gold instructions for use (ifu) warns not to leave artery completely blocked for more than 3 minutes to prevent limb ischemia.Check pedal pulse periodically to confirm whether or not flow remains in the vessels.

Event Description

Two different femostop devices were used to close an access site after a stent was implanted to treat stemi.During recovery, the patient developed a hematoma at the access site, roughly the size of the palm of his hand.The patient complained of discomfort and pain in the leg.The next day the patient was sent to surgery as the hematoma had grown to roughly the size of a volleyball.It was noted that the access site did not initially close.The access site was at the bifurcation.Please reference 2648612-2018-00007 for other femostop gold device.

• 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: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 7228447
• MDR Text Key: 98582195
• Report Number: 2648612-2018-00006
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2018
• 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
• Treatment: FEMOSTOP GOLD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR