MAUDE Adverse Event Report: DATASCOPE CORP. SENSATION PLUS 7.5FR. 40CC IAB WITH ACCESSORIES, US ONLY; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0568-01U
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Corrected field :d4 ( udi #, model #,catalog #).Updated fields: b4,e1(event site state), d4( lot #,exp.Date )g3, g6, h2,h3,h4, h6(investigation findings, type of investigation, investigation conclusions), h11.The product was returned with the membrane completely unfolded and blood on the exterior of the catheter and between the catheter and the sheath.The returned sheath was over the catheter and partially covering half of the balloon.The extender tubing was also returned.A kink was found on the catheter tubing and inner lumen approximately 25.7cm from iab tip.The inner lumen was found occluded with dried blood.The occlusion was unable to be cleared.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal and extender tubing was performed and no leaks were detected.The iab was placed on the cardiosave pump and the iab did not inflate and a catheter restriction alarm occurred on the pump.The condition of the iab as received indicated a kink in the iab.This restricted the gas passage and resulted in the catheter restriction alarm.The evaluation confirmed the reported problem.The 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 non-conforming 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.
Additional Manufacturer Narrative
D4 # the udi is incomplete due to the absence of the lot number, expiration date, and manufacturing date.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).
Event or Problem Description
It was reported that the intra-aortic balloon (iab) had a catheter restriction alarm on insertion.

• Brand Name: SENSATION PLUS 7.5FR. 40CC 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: henry pena ; 15 law drive; fairfield, NJ 07004
• MDR Report Key: 21216705
• Report Number: 2248146-2025-0000043
• Device Sequence Number: 3568729
• Product Code: DSP
• UDI-Device Identifier: 10607567109565
• UDI-Public: (01)10607567109565(10)3000423880(17)240910(11)270910
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K063525
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2025

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: 0684-00-0568-01U
• Device Catalogue Number: 0684-00-0568-01U
• Device Lot Number: 3000423880
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2025
• Supplement Date Received by Manufacturer: 02/24/2025
• Initial Report FDA Received Date: 01/23/2025
• Supplement Report FDA Received Date: 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown