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

Model Number	0684-00-0480-10
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the linear 40cc balloon catheter did not pass through the sheath from the initially opened package.Subsequently, a new package was opened, the other balloon was used, and it successfully passed through the sheath.No harm to the patient reported.
Additional Manufacturer Narrative
Event site name: (b)(6).Event site address: (b)(6).Upon completion of the investigation into this event a follow up report will be submitted.

• Brand Name: Linear 7.5Fr 40cc IAB with Accessories (APA) (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: 50784205
• Report Number: 2248146-2026-0001530
• Device Sequence Number: 21186124
• Product Code: DSP
• UDI-Device Identifier: 10607567113159
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K041281
• 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: Physician
• 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: 0684-00-0480-10
• Device Catalogue Number: 0684-00-0480-10
• Device Lot Number: 3000371515
• 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: 08/25/2026
• Initial Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Sex: Unknown
• Patient Weight: 222 LB