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 Code	Material Rupture (1546)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reporter that a mega 8fr.50cc intra-aortic balloon (iab) ruptured while providing mechanical circulatory support to a critically ill patient, necessitating removal and replacement of the device.The event resulted in patient harm.
Additional Manufacturer Narrative
E.Initial reporter.Event site name: new york presbyterian hosp-cornell contact person name: silverio mercado.Upon completion of the investigation into this event a follow up report will be submitted.

• 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: 50114165
• Report Number: 2248146-2026-0001356
• Device Sequence Number: 5252979
• Product Code: DSP
• UDI-Device Identifier: 10607567109619
• UDI-Public: (01)10607567109619(10)3000511513(17)281107(11)251107
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K133074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 0684-00-0296-01U
• Device Catalogue Number: 0684-00-0296-01U
• Device Lot Number: 3000511513
• 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: 07/13/2026
• Supplement Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 08/03/2026
• Supplement Report FDA Received Date: 09/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/07/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 63 YR
• Patient Sex: Male