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 Codes	Leak/Splash (1354); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Correction field: d10,g2, g7 updated fields: d1brand name, d3, d4 expiry date, version or model number, catalog number and udi number,e2,e3, b4, d9, g3, g4 (pma 510k), g6, h2, h6 (problem code, type of investigation, investigation findings, investigation conclusions, component code), h11 please revert the a1(patient id) and d8(device serviced by third party) for balloon iab d8 (device serviced by third party) should be blank the iab was returned with the membrane completely unfolded and blood on the exterior of the catheter and between the catheter and the sheath.The extender and pressure tubing were also returned.Two kinks were observed on the catheter tubing approximately 46.2cm and 76.2cm from iab tip.An underwater leak test of the balloon, catheter, y fitting, extracorporeal, extender and pressure tubing was performed and no leaks were detected.The iab was placed on the cardiosave pump and the iab fully inflated and deflated.The iab then pumped for two hours which represents one complete autofill cycle.The iab pumped normally and no alarm sounded from the pump.The reported problem cannot be confirmed by the evaluation.The failure mode is addressed in the risk file and is operating within its risk profile.The ifu addresses 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.Based on the rational provided above, no escalation to the capa process 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: 50171487
• Report Number: 2248146-2026-0001364
• Device Sequence Number: 12829658
• Product Code: DSP
• UDI-Device Identifier: 10607567108605
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K133074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2026

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: 3000508987
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/07/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2026
• Supplement Date Received by Manufacturer: 09/22/2026
• Initial Report FDA Received Date: 08/07/2026
• Supplement Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2025
• 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 IABP
• Patient Sex: Unknown