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	Inability to Auto-Fill (1044); Material Rupture (1546)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/28/2025
Type of Reportable Event	Death
Event or Problem Description
During the initial attempt to use the iabp catheter, the device could not be advanced and positioned as intended.The air-fill function did not perform as expected.The user confirmed that no excessive force was applied during insertion.Upon further evaluation, the iabp balloon was found to be ruptured, with blood observed within the balloon lumen.The patient was in critical condition, required resuscitative measures, and subsequently expired.
Additional Manufacturer Narrative
(b)(6) a supplemental report will be submitted upon completion of our investigation.
Additional Manufacturer Narrative
Updated fields b4 d9 g3 g6 h2 h3 h6 type of investigation findings investigation conclusions h11.Corrected field h6 medical device problem code.Since the product was not received for evaluation so unable to evaluate the root cause of failure iab leak the iabp balloon was found to have ruptured with blood inside.An intra aortic balloon iab leak is the loss of integrity in the balloon membrane or its connections allowing blood or gas to enter or escape.Iab leaks can result in the following.1 user not following instructions per ifu mishandling misuse of device.2 membrane folding resistance.3 patient related factors such as plaque abrasion.4 off label use.
Event or Problem Description
N/a.

• 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: 24425473
• Report Number: 2248146-2026-0000719
• Device Sequence Number: 16094425
• Product Code: DSP
• UDI-Device Identifier: 10607567106564
• UDI-Public: (01)10607567106564(10)3000429690(17)271107(11)241107
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K041281
• Number of Events Summarized: 1
• Summary Report (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,Followup
• Report Date (Section B): 03/25/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0684-00-0480-01
• Device Catalogue Number: 0684-00-0480-01
• Device Lot Number: 3000429690
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2026
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/07/2024
• 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: IABP.
• Outcome Attributed to Adverse Event: Death
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 46 KG