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	Fluid/Blood Leak (1250); Difficult to Remove (1528); Material Rupture (1546)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/31/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Fse received a phone call from the sr in cathlab regarding sensation plus 50cc intra aortic balloon (iab) that they had another balloon perforation on a patient.On the (b)(6) 2026 during an angiogram the patient needed a iabp which was inserted without any difficulty.The patient went for his cabg on thursday and they continued with the counterpulsation support till friday ((b)(6) 2026) morning.The dr gave instruction at about 06h45 that the patients balloon can be removed as he no longer needs the support from the pump.When the icu sr wanted to remove the balloon she could not and she noticed that there was dried out blood spots in the helium tubing.The dr was notified and they attempted to remove the balloon in icu and in theatre without any success.The patient had to be airlifted to another hospital where there was a vascular surgeon on call and the balloon had to be removed surgically in theatre.
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.

• 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: 50514637
• Report Number: 2248146-2026-0001472
• Device Sequence Number: 10678104
• Product Code: DSP
• UDI-Device Identifier: 10607567108605
• UDI-Public: (01)10607567108605(10)3000495519(17)280821(11)250821
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K133074
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 0684-00-0576-01
• Device Catalogue Number: 0684-00-0576-01
• Device Lot Number: 3000495519
• 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: 08/06/2026
• Initial Report FDA Received Date: 08/30/2026
• Date Device Manufactured: 08/21/2025
• 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: CS300 Intra-Aortic Balloon Pump (IABP)
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 231 LB