MAUDE Adverse Event Report: Datascope Corp. Sensation 7Fr 40cc IAB with Accessories (Turkey); System, Balloon, Intra-Aortic And Control

Model Number	0684-00-0470-09
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	08/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use, while placing the sensation 40cc balloon catheter, the user stated that the catheter failed to advance due to damage to the distal tip and that the procedure was continued with a new catheter.The iab inserted prior to surgery could not be withdrawn when removal was attempted during the procedure.Examination after removal revealed damage to the distal tip.Surgical intervention was not required for the balloon catheter removal.No harm to the patient reported.
Additional Manufacturer Narrative
Event site name: (b)(6) hospital.Initial reporter occupation: perfusionist.Upon completion of the investigation into this event a follow up report will be submitted.

• Brand Name: Sensation 7Fr 40cc IAB with Accessories (Turkey)
• 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: 50710095
• Report Number: 2248146-2026-0001516
• Device Sequence Number: 18794580
• Product Code: DSP
• UDI-Device Identifier: 10607567113135
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K063525
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 09/10/2026

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: 0684-00-0470-09
• Device Catalogue Number: 0684-00-0470-09
• Device Lot Number: 3000515567
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2026
• Initial Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Unknown
• Patient Weight: 211 LB