MAUDE Adverse Event Report: DATASCOPE CORP. LINEAR 7.5FR. 34CC IAB (WITH APA); SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0479-02
Medical Device Problem Codes	Burst Container or Vessel (1074); Leak/Splash (1354); Optical Problem (3001)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/29/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
Due to character limitation in e1, full initial reporter name: (b)(6).A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported first that during intra-aortic balloon (iab) therapy, a failure occurred in the fiber optic sensor module, resulting in the balloon rupturing inside the patient.Although no complications directly related to the balloon rupture were reported, the patient subsequently died.
Additional Manufacturer Narrative
Updated fields: b4, d9, g1 (contact person mfg site), g3, g6, h2, h3, h6 (type of investigation, investigation findings, component codes and investigation conclusions), h11.No decon or visual inspection performed since product was not returned and could not be evaluated.Therefore, we were unable to confirm or determine a root cause for the reported failure.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h6 (medical device problem code and investigation conclusions), h11.D4 serial should be left blank.Kindly revert this field.No decon or visual inspection performed since product was not returned and could not be evaluated.Therefore, we were unable to confirm or determine a root cause for the reported failure.The failure mode is addressed in the risk file and is operating within its risk profile.The ifu addresses the reported failure.There were no ncmrs identified which could cause or contribute to the reported failure.The investigation does not indicate that the device was inadvertently released as non-conforming or an adulterated product or was a counterfeit.The complaint history review did not identify an adverse trend (increase in number of complaints over past three (3) months).

• Brand Name: LINEAR 7.5FR. 34CC IAB (WITH APA)
• 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: 22396736
• Report Number: 2248146-2025-0000345
• Device Sequence Number: 14652564
• Product Code: DSP
• UDI-Device Identifier: 10607567106540
• UDI-Public: (01)10607567106540(10)3000349897(17)261117(11)231117
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Followup
• Report Date (Section B): 09/25/2025

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: 0684-00-0479-02
• Device Catalogue Number: 0684-00-0479-02
• Device Lot Number: 3000349897
• 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: 05/16/2025
• Supplement Date Received by Manufacturer: 07/23/2025; 09/17/2025
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 07/23/2025; 09/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/17/2023
• 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: CS300.
• Outcome Attributed to Adverse Event: Death
• Patient Age: 72 YR
• Patient Sex: Female