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

Model Number	0684-00-0480-01
Medical Device Problem Codes	Fluid/Blood Leak (1250); Difficult to Remove (1528); Material Rupture (1546)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/20/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Event site postal code: (b)(6).\ this event contains both an adverse event and a product problem.Due to a temporary system limitation associated with recent fda emdr system enhancements, only the adverse event designation could be transmitted in the current submission.Product problem details are included within this report.A supplemental mdr will be submitted once the emdr utility has been updated to support transmission of both event classifications.\ \ upon completion of the investigation into this event a follow up report will be submitted.
Event or Problem Description
It was reported that brownish fluid was observed in the helium tubing following insertion of the linear 7.5fr.40cc intra-aortic balloon (iab) catheter in the intensive care unit (icu).The fluid became blood-stained over a period of approximately two hours, and the cardiosave intra-aortic balloon pump (iabp) was stopped.The user suspected rupture of the balloon, and the iab catheter was surgically removed in the operating room (or) after the patient was transitioned to extracorporeal membrane oxygenation (ecmo) support.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: h2, h11, g6, g3, h6 (clinical code)\ upon completion of the investigation into this event a follow up report will be submitted.

• Brand Name: Linear 7.5Fr. 40cc 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: 50851394
• Report Number: 2248146-2026-0001554
• Device Sequence Number: 13250216
• Product Code: DSP
• UDI-Device Identifier: 10607567106564
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K041281
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse Practitioner
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 0684-00-0480-01
• Device Catalogue Number: 0684-00-0480-01
• Device Lot Number: 3000449608
• 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: 08/26/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/29/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARDIOSAVE (IABP), (ECMO) system,Terumo sheath
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown