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

Model Number	0684-00-0470-01C
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.Complaint record id (b)(4).
Event or Problem Description
It was reported that, while using sensation 7fr.40cc intra-aortic balloon pump (iabp), the patient's electrocardiogram (ecg) was pacing abnormalities and unable to perform pacing; simultaneously, due to the fiber optic failure, the iabp could not provide normal counterpulsation.No harm or injury to the patient was reported.
Additional Manufacturer Narrative
Due to character limit: e1 (event site name) (b)(6) hospital (b)(6), (telephone) (b)(6).Updated fields:b4,,d4(version or model,exp.Date, udi),d9,e1(initial reporter)e3,g3,g6,h2,h3,h4,h6(type of investigation, investigation findings, component), h11 the hospital contacted an engineer after a problem was discovered during iabp therapy when the fiber optic balloon malfunctioned preventing proper pump function.The device was shut down and therapy continued using a replacement balloon with no patient injuries reported.It remains unclear whether the issue was related to the balloon or the machine and no third party engineers were involved.The fault was not fully resolved although the replacement fiber optic balloon functioned normally.The patient had the iabp placed at the bedside and experienced a fiber optic failure overnight along with ecg pacing abnormalities which prevented effective counterpulsation.The fiber optic sensor failure resulted in loss of pressure waveform alarms and inability of the pump to detect the sensor signal due to possible kink break or connector issue.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h11 corrected fields: d4 (lot and udi), h6 (investigation findings and investigation conclusions).

• Brand Name: SENSATION 7FR. 40CC IAB (CHINA)
• 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: 24430439
• Report Number: 2248146-2026-0000723
• Device Sequence Number: 10393279
• Product Code: DSP
• UDI-Device Identifier: 10607567109374
• UDI-Public: (01)10607567109374(10)3000421044(17)270930(11)240930
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K063525
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/08/2026

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: 0684-00-0470-01C
• Device Catalogue Number: 0684-00-0470-01C
• Device Lot Number: 3000421044
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2026
• Supplement Date Received by Manufacturer: 03/25/2026; 04/08/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 03/30/2026; 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2024
• 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: INTRA-AORTIC BALLOON PUMP (IABP)
• Patient Age: 49 YR
• Patient Sex: Male