MAUDE Adverse Event Report: Datascope Corp. Linear 7.5Fr. 34cc IAB; System, Balloon, Intra-Aortic And Control

Model Number	0684-00-0479-01
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the physician inserted a linear 34cc balloon catheter.Approximately five minutes after insertion, during a routine check of the machine and catheter function, blood return was observed in the tubing.The catheter was immediately removed and replaced with a new catheter.No harm to the patient 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: Linear 7.5Fr. 34cc 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: 50852280
• Report Number: 2248146-2026-0001556
• Device Sequence Number: 21220751
• Product Code: DSP
• UDI-Device Identifier: 10607567106557
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 09/22/2026

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: 0684-00-0479-01
• Device Catalogue Number: 0684-00-0479-01
• Device Lot Number: 3000522529
• 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: 08/31/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 145 LB