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	Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the physician was unable to advance the mega 50cc balloon catheter because it had become kinked.Another balloon catheter was inserted to continue treatment.The engineer inspected the device and ruled out any device malfunction.No harm to the patient reported.Resistance was encountered during insertion, advancement of the iab.The kink was located on the tip of the catheter.
Additional Manufacturer Narrative
Event site name: (b)(6) hospital.Event site postal code: (b)(6).Event site telephone: (b)(6).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: 50913348
• Report Number: 2248146-2026-0001578
• Device Sequence Number: 14903971
• Product Code: DSP
• UDI-Device Identifier: 10607567107301
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K133074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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: 0684-00-0498-01
• Device Catalogue Number: 0684-00-0498-01
• Device Lot Number: 3000452583
• 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: 09/08/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/10/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 149 LB