MAUDE Adverse Event Report: GETINGE / DATASCOPE CORP. GETINGE INTRAAORTIC BALLOON PUMP; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number CS300

Device Problems Material Rupture (1546); Protective Measures Problem (3015); Noise, Audible (3273)

Patient Problem Pseudoaneurysm (2605)

Event Date 05/22/2022

Event Type  Injury  

Event Description

The iabp was implanted into the left femoral artery without complications.Two days later, an alarm stating "check iabp catheter" and a hissing sound was heard.Iabp was removed without difficulty.The balloon was noted to be ruptured.A groin pseudoaneurysm was present in the left groin.Vascular surgery was consulted and the patient received an injection of thrombin to treat bleeding of the pseudoaneurysm.

• Brand Name: GETINGE INTRAAORTIC BALLOON PUMP
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): GETINGE / DATASCOPE CORP.
• MDR Report Key: 15076595
• MDR Text Key: 296400622
• Report Number: MW5111011
• Device Sequence Number: 1
• Product Code: DSP
• 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: 06/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CS300
• Device Catalogue Number: 0684-00-0470-01
• 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
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White