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

Model Number	0684-00-0576-01
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Another reporter: (b)(6).The product has been returned to the manufacturer,but is pending investigation.Once the investigation is completed a supplemental report with our findings will be submitted complaint record id (b)(4).
Event or Problem Description
It was reported by the customer through emergency support program that the sensation plus 50cc had fiber optic (fo) sensor failure alarm occurred immediately after catheter placement.Esp personnel instructed aggie to remove the fo cable from the pump, and to reinsert the cable ensuring the arrow on the fo cable and the arrow on the pump align.Aggie followed the instructions multiple times, however this did not resolve the alarm.Esp personnel recommended switching to the inner lumen for the ap source.Aggie stated she would follow these recommendations.She was unable to provide the sn at the time of call due to patient prioritization.Esp personnel stated he would follow up with her to collect the information.She appreciated the support provided and had no other questions.Esp personnel followed up with aggie multiple times and was able to obtain product surveillance information on the balloon catheter.She stated the physician opted to remove the sensation plus 50cc and insert a mega 40cc.Esp personnel explained that a biohazard kit would be sent to the manager to return the sensation plus 50cc balloon catheter back to getinge due to the fo sensor failure.No harm or injury to the patient was reported.
Additional Manufacturer Narrative
Updated fields: b4,g3,g6,h2,h6(type of investigation, investigation findings, investigation conclusions),h11.The iab was returned fully unfolded with blood present on the catheter exterior, and the inner lumen was occluded with dried blood that could not be cleared.Sensor testing met specifications.The investigation could not confirm the reported event.Lot history and complaint reviews identified no related nonconformances, adverse trends, or product issues.The failure mode is addressed in the risk file and ifu and remains within acceptable risk.No capa escalation is required.

• Brand Name: SENSATION PLUS 8FR. 50CC IAB & ACCESSORIES (W/PRESSURE TUBES, NO STYLET)
• 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: 24851471
• Report Number: 2248146-2026-0000873
• Device Sequence Number: 18374513
• Product Code: DSP
• UDI-Device Identifier: 10607567108605
• UDI-Public: (01)10607567108605(10)3000511517(17)281105(11)251105
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2026

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: 0684-00-0576-01
• Device Catalogue Number: 0684-00-0576-01
• Device Lot Number: 3000511517
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2026
• Supplement Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 04/11/2026
• Supplement Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2025
• 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: IABP
• Patient Age: 87 YR
• Patient Sex: Female
• Patient Weight: 74 KG