MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR, LLC MAQUET LINEAR 7.5 FR 40CC; IABP CATHETER AND BALLOON

Model Number 6084-00-0480-01U

Device Problem Device Contamination with Body Fluid (2317)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/10/2016

Event Type  Injury  

Event Description

Noted blood within the iabp catheter tubing suspected balloon rupture.Cath.Removed at bedside.No pt.Harm noted.Dates of use: (b)(6) 2016.Is the product compounded: no.Is the product over-the-counter: no.Event abated after stopped or dose reduced: yes.

• Brand Name: MAQUET LINEAR 7.5 FR 40CC
• Type of Device: IABP CATHETER AND BALLOON
• Manufacturer (Section D): MAQUET CARDIOVASCULAR, LLC; wayne NJ 07470
• MDR Report Key: 6105555
• MDR Text Key: 60095255
• Report Number: MW5066050
• Device Sequence Number: 1
• Product Code: DSP
• 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: 10/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6084-00-0480-01U
• Device Lot Number: 3000036210
• 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: 84 YR
• Patient Weight: 85