MAUDE Adverse Event Report: ARTERIAL SHEATH; INTRODUCER, CATHETER

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/23/2023

Event Type  Injury  

Event Description

Patient from cath lab more than 24 hours had an arterial sheath in place.Noted that patient was bleeding out not from the insertion site of the sheath, but from the connection port closest to the sheath.Connections were tight and secured, and when the stopcock was closed off to the patient/artery, no bleeding was noted, but when opened, there was a squirting of blood from the tubing near the connection port.Arterial sheath was removed and when inspected closely, a small crack/hole was noted on the tubing.

• Brand Name: ARTERIAL SHEATH
• Type of Device: INTRODUCER, CATHETER
• MDR Report Key: 16515951
• MDR Text Key: 311125046
• Report Number: MW5115633
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention