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	04/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h3, h6(type of investigation, investigation findings, conclusion), h11 the iab was returned with the membrane completely unfolded and blood on the interior and exterior of the catheter and between the catheter and the sheath.The extender tubing was also returned.An underwater leak test of the balloon catheter y fitting extracorporeal and extender tubing was performed and a leak was detected on the membrane approximately 1.5cm from the rear seal measuring 0.013cm in length.The reported problem was most likely triggered by a leak which was found on the membrane.Under magnification a whitish patch was observed around the leak.This whitish patch is the typical appearance of an abrasion mark which is caused by calcified plaque in the aorta.A lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.The failure mode is addressed in the risk file and is operating within its risk profile.The ifu addresses the reported failure.There were no ncmrs identified which could cause or contribute to the reported failure.The investigation does not indicate that the device was inadvertently released as nonconforming or an adulterated product or was a counterfeit.The complaint history review did not identify an adverse trend increase in number of complaints over past three 3 months.Based on the rational provided above no escalation to the capa process is required.
Event or Problem Description
During use, intra-aortic balloon (iab) catheter inserted into patient, there was blood observed in the helium line.Balloon was explanted, new balloon inserted and was operational.There was no patient harm or injury reported.
Additional Manufacturer Narrative
(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).

• 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: 24980012
• Report Number: 2248146-2026-0000948
• Device Sequence Number: 10468308
• Product Code: DSP
• UDI-Device Identifier: 10607567108605
• UDI-Public: (01)10607567108605(10)3000501992(17)280930(11)250930
• Combination Product (Y/N): N
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2026

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: 3000501992
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2026
• Supplement Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 04/24/2026
• Supplement Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown