MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ANGIOSEAL 6 FR; FEMOSTOP

Lot Number 610130

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

Patient Problem Pseudoaneurysm (2605)

Event Date 06/09/2016

Event Type  Injury  

Event Description

Pt underwent cardiac catheterization.At the end of the procedure, a femostop was deployed.The pt developed pseudoaneurysm.The femostop was removed by a surgeon, who observed the device in the subcutaneous tissue with no clear obstruction.The pt maintained peripheral pulses.There was no need for surgical repair.The pt was observed for one day with f/u doppler and was discharged home on (b)(6)2016.

• Brand Name: ANGIOSEAL 6 FR
• Type of Device: FEMOSTOP
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; st. paul MN 55117
• MDR Report Key: 5769037
• MDR Text Key: 48810928
• Report Number: MW5063215
• Device Sequence Number: 1
• Product Code: DXC
• 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: 06/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 610130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/29/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 73 YR
• Patient Weight: 59