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	09/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that during use of linear 34cc balloon catheter they had a leak and blood entered the catheter.Another ballon catheter was inserted to resume therapy.No harm to the patient reported.There was no difficulty experienced inserting the intra-aortic balloon (iab) catheter.Sheath was used during insertion.Blood was first observed within the iab catheter 5 mins after insertion.
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: 50928296
• Report Number: 2248146-2026-0001582
• Device Sequence Number: 16139669
• Product Code: DSP
• UDI-Device Identifier: 10607567106557
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K041281
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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: 3000394441
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/07/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 151 LB