MAUDE Adverse Event Report: Datascope Corp. MEGA 8Fr. 50cc IAB with Accessories, US Only; System, Balloon, Intra-Aortic And Control

Model Number	0684-00-0296-01U
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Rupture (1546); Failure to Unfold or Unwrap (1669); Obstruction of Flow (2423); 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
During an emergency support program call, an rn reported an iab restriction alarm on a cardiosave intra-aortic balloon pump (iabp) while using a mega 8fr.50cc iab catheter.During initial troubleshooting, no visible blood was identified in the helium tubing; however, several minutes later, the customer observed serosanguinous, pinkish/rust-colored fluid in the large-bore helium tubing of the iab catheter.Troubleshooting was discontinued, and the customer was advised to disconnect the iab catheter from the cardiosave and clamp the iab.The customer completed these actions while on the call, while another team member contacted the cardiothoracic surgeon to facilitate iab removal or replacement.
Additional Manufacturer Narrative
Event site name: (b)(6).Iab leak: the intra-aortic balloon (iab) leak occurred due to loss of balloon system integrity resulting from mechanical damage to the balloon catheter component due to sharp objects or severe kinks, allowing unintended blood or gas ingress.Alarm, catheter restriction: 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/volume conditions and enters standby.This issue continues to be monitored within the manufacturer¿s quality system.

• Brand Name: MEGA 8Fr. 50cc 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: 50770932
• Report Number: 2248146-2026-0001531
• Device Sequence Number: 21473167
• Product Code: DSP
• UDI-Device Identifier: 10607567109619
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K091449
• 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): 09/15/2026

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: 0684-00-0296-01U
• Device Catalogue Number: 0684-00-0296-01U
• Device Lot Number: 3000518871
• 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: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/16/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARDIOSAVE IABP, Mechanical ventilator.
• Patient Age: 86 YR
• Patient Sex: Male
• Patient Weight: 167 LB