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

Model Number	0684-00-0568-01
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
(b)(6) the clinical nurse specialist, called with balloon information for a perforation.She explained the patient now has her 5th balloon in place.(b)(6) stated all the balloons were placed axillary while the patient awaits a heart transplant.Axillary disclaimer was provided.This complaint is for the balloon placed (b)(6) 2025.It had a balloon perforation.The iab was discarded by staff.There was no patient harm or injury reported.
Additional Manufacturer Narrative
(b)(6) the clinical nurse specialist, called with balloon information for a perforation.She explained the patient now has her 5th balloon in place.(b)(6) stated all the balloons were placed axillary while the patient awaits a heart transplant.Axillary disclaimer was provided.This complaint is for the balloon placed (b)(6) 2025.It had a balloon perforation.The iab was discarded by staff.There was no patient harm or injury reported.

• Brand Name: SENSATION PLUS 7.5FR. 40CC IAB & ACCESSORIES
• 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: 24276486
• Report Number: 2248146-2026-0000666
• Device Sequence Number: 15943361
• Product Code: DSP
• UDI-Device Identifier: 10607567108063
• UDI-Public: (01)10607567108063
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K122628
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/06/2026

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: 0684-00-0568-01
• Device Catalogue Number: 0684-00-0568-01
• 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: 01/14/2026
• Initial Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: SENSATION PLUS 40CC,50CC AND CARDIOSAVE
• Patient Age: 43 YR
• Patient Sex: Female
• Patient Weight: 106 KG