MAUDE Adverse Event Report: DATASCOPE CORP. SENSATION 7FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0470-01
Medical Device Problem Codes	Obstruction of Flow (2423); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A complaint was received via a direct call to the emergency support program regarding sensation 7fr.40cc intra aortic balloon (iab) that fiber optic sensor failure alarm on a cardiosave device during use.No patient harm or injury was reported.Troubleshooting was performed with the nurse including verification of proper fo cable connection.The fse was guided to transition from the fiber optic sensor to a transducer pressure source and to label the fo cable as not for use.Following transition, the inner lumen was identified as clotted, and the fse capped and labeled the lumen and transitioned to an alternate arterial access (radial arterial line).The issue was determined not to be a device malfunction.The caller reported no additional needs after support was provided.
Additional Manufacturer Narrative
Due to characterization limit e1 event site name is (b)(6).Additional mail id (b)(6).Product was not returned so an exact cause of the issue could not be identified.However based on our investigation a fo failure and clotted lumen can occur due to one or more of the following probable causes a fiber optic sensor failure in an intra aortic balloon refers to the malfunction or loss of signal from the fiber optic pressure sensor within the intra aortic balloon catheter.This sensor is responsible for accurately detecting and transmitting real time aortic pressure waveforms to the iabp console which are critical for timing the inflation and deflation of the balloon during cardiac cycles.Causes of a sensor failure ¿ optical sensor kink ¿ break in sensor ¿ connector issue clotted inner lumen clotted inner lumen is a blockage of the catheter inner channel and it is typically caused by blood clot formation within that lumen.When the inner lumen becomes occluded by a blood clot it can no longer transmit accurate arterial pressure.Inner lumen importance the inner lumen of an iab catheter serves the purpose of monitoring the arterial pressure waveforms.Causes of clotted inner lumen ¿ inadequate flushing of the inner lumen ¿ kink in the inner lumen ¿ iab remaining inactive or on standby for more than 30 minutes.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h11.Corrected fields: d7a.

• Brand Name: SENSATION 7FR. 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: 24725286
• Report Number: 2248146-2026-0000824
• Device Sequence Number: 10330911
• Product Code: DSP
• UDI-Device Identifier: 10607567106779
• UDI-Public: (01)10607567106779(10)3000469258(17)280421(11)250421
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K063525
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2026

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: 0684-00-0470-01
• Device Catalogue Number: 0684-00-0470-01
• Device Lot Number: 3000469258
• 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: 03/06/2026
• Supplement Date Received by Manufacturer: 05/08/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/21/2025
• 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
• Patient Age: 85 YR
• Patient Sex: Male
• Patient Weight: 72 KG