MAUDE Adverse Event Report: DATASCOPE CORP. SENSATION PLUS 8FR 50CC IAB WITH ACCESSORIES (W/PRESSURE TUBES, NO STYLET, W/O S; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0576-05
Medical Device Problem Codes	Failure to Sense (1559); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that customer called through emergency service programme, requesting for an assistance regarding fiber optic sensor alarm that appeared during use of intra aortic balloon.The customer stated the fo balloon catheter was inserted in the cardiac cath lab approximately 4 hours prior calling the clinical line.However, the pump alarmed a few minutes prior to calling.The getinge representative recommenended removing and re-inserting the fo cable, ensuring the arrows align.This did not resolve the sensor failure alarm.Further the getinge representative requested customer to remove the fo cable from the pump and placing a note that read, ¿do not use.Customer switched to the inner lumen without difficulty.After this the customer stated all waveforms and blood pressure indices were appropriate.No patient harm or injury reported.
Additional Manufacturer Narrative
The additional reporter's name is (b)(6).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
N/a.
Additional Manufacturer Narrative
Updated fields: b4,g3, g6,h2,h6(type of investigation, investigation conclusions, investigation findings),h11 corrected fields: d10, h6 (medical device ¿ problem code) the fo cable was removed and marked ¿do not use.¿ the nurse switched to monitoring via the inner lumen without difficulty, and all waveforms and blood pressure readings were appropriate.No patient harm occurred.Product surveillance information was collected, and relevant team members were notified.Since the product was not returned, we were unable to evaluate the device.Based on the provided description, the fiber-optic cable failure occurred shortly after the patient was transferred to the cvicu.Since the device was not returned for evaluation, it is not possible to determine the exact timing or mechanism of the failure.A likely root cause is improper handling or physical stress on the cable during or following transport, which may have compromised its functionality.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).Based on the rational provided above, no escalation to the capa process is required.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h11.Corrected fields: e1 (initial reporter), e3, g2, h6 (type of investigation, investigation findings).Additional point of contact: (b)(6).Due to character limitation in block d1: brand name: sensation plus 8fr 50cc iab with accessories (w/pressure tubes, no stylet, w/o statlock) (china).
Event or Problem Description
N/a.

• Brand Name: SENSATION PLUS 8FR 50CC IAB WITH ACCESSORIES (W/PRESSURE TUBES, NO STYLET, W/O S
• 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: 23448482
• Report Number: 2248146-2025-0000680
• Device Sequence Number: 9007983
• Product Code: DSP
• UDI-Device Identifier: 10607567109381
• UDI-Public: (01)10607567109381(10)3000472788(17)280502(11)250502
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K133074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/24/2026

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: 0684-00-0576-05
• Device Catalogue Number: 0684-00-0576-05
• Device Lot Number: 3000472788
• 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: 10/13/2025
• Supplement Date Received by Manufacturer: 12/09/2025; 01/24/2026
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 12/10/2025; 01/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/02/2025
• 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: PUMP.; UNKNOWN.
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 66 KG