MAUDE Adverse Event Report: DATASCOPE CORP. SENSATION 7FR. 34CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0469-01
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint was about a fiber optic sensor failure during use of an intra aortic balloon pump.The nurse reported a sensor failure alarm but confirmed there was no kink or damage in the cable and reconnection was already attempted.Guidance was provided to recheck proper connection and switch to transducer mode for pressure monitoring.The cable was labeled as faulty and not to be used.No patient harm was reported.The issue involves loss of sensor signal due to possible causes like cable kink break or connector problem.This can result in poor waveform failure alarms and inability to monitor pressure.
Event or Problem Description
It was reported by the customer via emergency support program line, that the intra aortic balloon (iab) sensation 34cc had a fiber optic sensor failure alarm.There were no patient harm or injury was reported.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h11.Corrected fields: h6 (type of investigation) and d10.

• Brand Name: SENSATION 7FR. 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: 24902169
• Report Number: 2248146-2026-0000906
• Device Sequence Number: 9727497
• Product Code: DSP
• UDI-Device Identifier: 10607567106755
• UDI-Public: (01)10607567106755(10)3000432538(17)271125(11)241125
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 05/10/2026

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: 0684-00-0469-01
• Device Catalogue Number: 0684-00-0469-01
• Device Lot Number: 3000432538
• 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: 03/27/2026
• Supplement Date Received by Manufacturer: 05/10/2026
• Initial Report FDA Received Date: 04/16/2026
• Supplement Report FDA Received Date: 05/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/25/2024
• 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: CARDIOSAVE
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 68 KG