MAUDE Adverse Event Report: Datascope Corp. Sensation Plus 8Fr. 50cc IAB with Accessories, US Only; System, Balloon, Intra-Aortic And Control

Model Number	0684-00-0576-01U
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the customer experienced difficulty inserting a sensation plus 8fr 50cc intra-aortic balloon (iab) catheter through the provided 8 french (fr) sheath.It was reported that the cardiovascular surgeon was unable to advance the iab catheter through the sheath and the catheter was subsequently discarded.A second sensation plus 8fr 50cc iab catheter was then used and was successfully inserted.No patient harm was reported.It was reported that on (b)(6) 2026, during an on-site discussion at (b)(6), the specifications of the sensation 50cc iab catheter were reviewed, including the importance of properly preparing the iab catheter prior to insertion and ensuring that the one-way valve remained on throughout the insertion process.The cardiovascular surgeon reported that the balloon had been prepared with the one-way valve on the device.
Additional Manufacturer Narrative
E.(b)(6).The serial number for the medical device referred to in this medical device report has not been received.An investigation was conducted regarding difficulty inserting a sensation plus 8 fr 50 cc intra aortic balloon iab catheter through the provided 8 fr sheath.Iab difficult or unable to insert through sheath.This failure mode occurs when the intra aortic balloon iab catheter cannot be advanced smoothly or at all through the supplied introducer sheath during insertion, resulting in increased insertion resistance, inability to progress the catheter, or complete obstruction of advancement.This condition may compromise proper placement of the iab, delay therapy initiation, or necessitate device replacement.Potential causes for difficult or unable to insert iab through sheath 1.Kinked or bent sheath.2.Unfolded sheath.3.Clotted sheath.4.Incorrect sheath size.5.Damaged sheath hub.6.Broken inner lumen.7.Kinked inner lumen.8.Kinked catheter.9.Unfolded membrane.This issue continues to be monitored within the manufacturer's quality system.

• Brand Name: Sensation Plus 8Fr. 50cc IAB with Accessories, US Only
• 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: 50912573
• Report Number: 2248146-2026-0001575
• Device Sequence Number: 17586525
• Product Code: DSP
• UDI-Device Identifier: 10607567109633
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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: 0684-00-0576-01U
• Device Catalogue Number: 0684-00-0576-01U
• Device Lot Number: 3000507487
• 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: 09/08/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/16/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 224 LB