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

Model Number	0684-00-0498-01
Medical Device Problem Codes	Difficult to Insert (1316); Difficult to Remove (1528); Material Integrity Problem (2978)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: h2, h11, g6, g3, h6 (health effect - clinical code) upon completion of the investigation into this event a follow up report will be submitted.

• Brand Name: MEGA 8Fr. 50cc IAB
• 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: 50514645
• Report Number: 2248146-2026-0001473
• Device Sequence Number: 10703198
• Product Code: DSP
• UDI-Device Identifier: 10607567107301
• UDI-Public: (01)10607567107301(10)3000474858(17)280508(11)250508
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K133074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/28/2026

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: 0684-00-0498-01
• Device Catalogue Number: 0684-00-0498-01
• Device Lot Number: 3000474858
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2026
• Initial Report FDA Received Date: 08/30/2026
• Date Device Manufactured: 05/08/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown