MAUDE Adverse Event Report: Datascope Corp. MEGA 7.5Fr. 30cc IAB with Accessories, US Only; System, Balloon, Intra-Aortic And Control

Model Number	0684-00-0294-01U
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by a direct call from the customer to the emergency support program, that during use of mega 30cc balloon catheter a restriction alarm was displayed on cardiosave pump and blood was observed in the helium tubing.The reporting icu nurse stated he had attempted to troubleshoot the alarm by pressing the start key.He was instructed to discontinue iab therapy immediately, disconnect the helium tubing from the pump, clamp the extracorporeal tubing, and notify the provider for immediate catheter removal.During follow-up approximately one hour later, the reporter confirmed that the iab catheter had been removed without complication and that no blood had reached the pump.No harm to the patient reported.
Additional Manufacturer Narrative
The intra aortic balloon (iab) leak occurred due to loss of balloon system integrity resulting from mechanical damage to the balloon membrane or catheter components, including membrane abrasions or tears, catheter perforation from sharp objects or severe kinking, inner lumen breaks or kinks, and seal failures at the balloon tip or rear seal, allowing unintended blood or gas ingress.A catheter restriction alarm occurs when the intra aortic balloon (iab) cannot properly inflate or deflate because airflow through the catheter or connected tubing is mechanically restricted.This restriction prevents the balloon from cycling normally, so the pump identifies abnormal pressure or volume conditions and enters standby.Based on the documented causes, the root causes fall into three categories: mechanical obstruction in the iab catheter or tubing.This includes any physical kink, bend, or compression in: the iab catheter itself, the extracorporeal tubing, the extender tubing.Root cause: air cannot move freely through the system because the airflow is restricted.This issue continues to be monitored within the manufacturers quality system.

• Brand Name: MEGA 7.5Fr. 30cc IAB with Accessories, US Only
• Common Device Name: System, Balloon, Intra-Aortic And Control
• Manufacturer (Section D): Datascope Corp.; 15 law drive; fairfield NJ 07004
• Manufacturer (Section G): Datascope Corp.; 15 law drive; fairfield NJ 07004
• Manufacturer Contact: ewelina chorlowska ; 15 law drive; fairfield, NJ 07004
• MDR Report Key: 50881759
• Report Number: 2248146-2026-0001565
• Device Sequence Number: 15937608
• Product Code: DSP
• UDI-Device Identifier: 10607567109572
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K120868
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0684-00-0294-01U
• Device Catalogue Number: 0684-00-0294-01U
• Device Lot Number: 3000526757
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/22/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 86 YR
• Patient Sex: Female
• Patient Weight: 156 LB