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 Codes	Difficult to Flush (1251); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product was not returned so an exact cause of the issue could not be identified.However, based on our investigation, a inner lumen clot can occur due to one or more of the following probable causes are as clotted inner lumen is a blockage of the catheter¿s inner channel, and it is typically caused by blood clot (thrombus) formation within that lumen.When the inner lumen becomes occluded by a blood clot, it can no longer transmit accurate arterial pressure.The inner lumen of an iab catheter serves the purpose of monitoring the arterial pressure waveforms.Causes of clotted inner lumen are inadequate flushing of the inner lumen, kink in the inner lumen, iab remaining inactive/standby for more than 30 minutes.
Event or Problem Description
A complaint was received via a direct call to the emergency support program.A nurse reported that the inner lumen of a sensation plus 7.5fr.40cc intra aortic balloon (iab) catheter was no longer flushing and could not be aspirated, with no blood return while in standby.The fse advised inner lumen was no longer patent and should be treated as such per hospital policy.No patient harm or injury was reported.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h11 corrected fields: h6 (investigation conclusions).
Event or Problem Description
N/a.

• 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: 24724196
• Report Number: 2248146-2026-0000829
• Device Sequence Number: 10139615
• Product Code: DSP
• UDI-Device Identifier: 10607567108063
• UDI-Public: (01)10607567108063(10)3000313728(17)260524(11)230524
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 05/08/2026

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 Expiration Date: 05/24/2026
• Device Model Number: 0684-00-0568-01
• Device Catalogue Number: 0684-00-0568-01
• Device Lot Number: 3000313728
• 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: 03/07/2026
• Supplement Date Received by Manufacturer: 05/08/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/24/2023
• 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: CARDIOSAVE.
• Patient Sex: Unknown