MAUDE Adverse Event Report: CENTURION PERCUTANEOUS SHEATH INTRODUCER

Lot Number 2015011250

Device Problems Air Leak (1008); Occlusion Within Device (1423)

Patient Problems Pulmonary Embolism (1498); Hypoxia (1918); Respiratory Distress (2045)

Event Date 01/14/2016

Event Type  Injury  

Event Description

Pt had a percutaneous sheath introducer, a 9 fr centurion intro- flex percutaneous sheath introducer with bonded hemostasis valve and side port with integral hemostasis valve/side port placed (b)(6) 2016 and was being used for iv meds and for monitoring cvp.On (b)(6) 2015 the line clotted off and developed air in line.Thought to be from user error.Small thrombus and air was aspirated from side port and was again hooked up to pressure bag for cvp monitoring.Again developed air and thrombus in line associated with respiratory distress and hypoxia along with diffuse pulmonary embolisms.Dates of use: (b)(6) 2016.Event abated after use stopped or dose reduced? no.

• Brand Name: PERCUTANEOUS SHEATH INTRODUCER
• Type of Device: PERCUTANEOUS SHEATH INTRODUCER
• Manufacturer (Section D): CENTURION; williamston MI 48895
• MDR Report Key: 5398165
• MDR Text Key: 37103173
• Report Number: MW5059792
• Device Sequence Number: 1
• Product Code: DYB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 2015011250
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Weight: 87