MAUDE Adverse Event Report: Datascope Corp. MEGA 7.5Fr. 40cc IAB with Accessories (APA), US Only; System, Balloon, Intra-Aortic And Control

Model Number	0684-00-0295-02U
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250); Leak/Splash (1354); Off-Label Use (1494); Obstruction of Flow (2423); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, g7, h2, h11 corrected fields: d4 serial (revert this field to blank, as it was inadvertently submitted initially), d8 (revert this field to blank, as it was inadvertently submitted initially), h6 (investigation findings and component codes).

• Brand Name: MEGA 7.5Fr. 40cc IAB with Accessories (APA), 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: 50537072
• Report Number: 2248146-2026-0001485
• Device Sequence Number: 5963083
• Product Code: DSP
• UDI-Device Identifier: 10607567109602
• UDI-Public: (01)10607567109602(10)3000534620(17)290220(11)260220
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K120868
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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,Followup
• Report Date (Section B): 09/18/2026

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: 0684-00-0295-02U
• Device Catalogue Number: 0684-00-0295-02U
• Device Lot Number: 3000534620
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/20/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2026
• Supplement Date Received by Manufacturer: 09/11/2026; 09/18/2026
• Initial Report FDA Received Date: 09/01/2026
• Supplement Report FDA Received Date: 09/17/2026; 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 125 LB