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

Model Number	0684-00-0295-05
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the puncture procedure, the customer found that the guidewire from the mega 40cc balloon catheter set was difficult to advance.To ensure the procedure could proceed smoothly, a new set of the product was used.After the replacement, the procedure progressed successfully.When taking photos at the site, customer found that the guidewire was bent.No harm or injury reported.
Additional Manufacturer Narrative
Event site name: (b)(6).Upon completion of the investigation into this event a follow up report will be submitted.

• Brand Name: MEGA 7.5 Fr. 40cc IAB (China)
• 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: 50786967
• Report Number: 2248146-2026-0001539
• Device Sequence Number: 10510824
• Product Code: DSP
• UDI-Device Identifier: 10607567109039
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,User Facility,Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/16/2026

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: 0684-00-0295-05
• Device Catalogue Number: 0684-00-0295-05
• Device Lot Number: 3000483747
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/16/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown