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	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer through emergency support program that nurse requesting assistance for a possible balloon perforation.Nurse requested review a screenshot which revealed discoloration in the helium tubing.Esp personnel recommended removing the helium tubing from the pump, notifying the physician and to prepare for balloon catheter removal.Esp personnel also visualized a video that showed blood reaching the pump.Esp personnel to nurse that the balloon catheter should not remain inactive for greater than 30 minutes due to potential risk of thrombus.Esp personnel was unable to collect product surveillance at the time of call due to nurse needing to prioritize patient care and asked her to keep the catheter and pump at the bedside.Esp personnel provided nurse with his phone number and asked her to call directly should she have any other questions or the need for troubleshooting assistance.Esp personnel followed up with nurse, and she reported the balloon catheter and sheath had been removed successfully.Esp personnel collected product surveillance and explained that a biohazard kit would be sent to her manager and requested the catheter be returned to getinge.Esp personnel asked nurse to send the pump to biomed.Nurse appreciated the support provided and had no other questions.No harm and injury was reported.
Additional Manufacturer Narrative
Another contact info: (b)(6).Due to characterization limit e1 event site name: (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, h11.Corrected field - d4 unique identifier (udi).
Additional Manufacturer Narrative
Other reporter: (b)(6).Updated fields: b4, d9, g3, g6, h2, h3, h6 (type of investigation, investigation findings, investigation conclusions), h11.Corrected fields: e1 (initial reporter).The iab was returned with the membrane fully unfolded and blood present inside and outside the catheter and between the catheter and sheath.The returned sheath was not a maquet product.An underwater leak test identified a 0.038 cm leak on the membrane approximately 15 cm from the iab tip.The damage appears to have been caused by a sharp object, leading to the reported issue.Lot history and complaint reviews found no related nonconformances, adverse trends, or evidence of counterfeit or adulterated product.The failure mode is addressed in the risk file and ifu and remains within the acceptable risk profile.No capa escalation is required.
Event or Problem Description
N/a.

• 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: 24797091
• Report Number: 2248146-2026-0000856
• Device Sequence Number: 21499467
• 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: WA
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/04/2026

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2026
• Supplement Date Received by Manufacturer: 04/24/2026; 05/04/2026
• Initial Report FDA Received Date: 04/07/2026
• Supplement Report FDA Received Date: 04/27/2026; 05/04/2026
• 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: CARDIOSAVE
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 82 KG