MAUDE Adverse Event Report: DATASCOPE CORP. LINEAR 7.5FR. 34CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0479-01
Medical Device Problem Code	Pacing Problem (1439)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer via emergency support program line, that the intra aortic balloon (iab) linear 34cc had unable to monitor arterial waveform or pressure.There were no patient harm or injury was reported.
Additional Manufacturer Narrative
The complaint was received through a direct call to the emergency support program and no patient harm or injury was reported.During the case the caller reported no arterial pressure reading with a no zero message on the cs300 while therapy continued normally using ecg triggering.Troubleshooting was performed and the catheter and pump were confirmed to be working as intended based on appropriate balloon waveforms and patient condition.The issue was identified as incorrect installation and venting of a non getinge transducer which was placed in the wrong direction with the vent cap on.Once the transducer was correctly oriented and vented a clean arterial pressure waveform was restored and the issue was confirmed as user error rather than device malfunction.
Additional Manufacturer Narrative
Updated fields - b4, g3, g6, h2, h11.After further review, an initial emdr for this complaint was incorrectly submitted.This is a non-reportable event, making it non-reportable to the fda.As a result, no follow up emdr is necessary.Please cancel this report 2248146-2026-0000821 in your database.
Event or Problem Description
N/a.

• Brand Name: LINEAR 7.5FR. 34CC IAB
• 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: 24710942
• Report Number: 2248146-2026-0000821
• Device Sequence Number: 17669683
• Product Code: DSP
• UDI-Device Identifier: 10607567106557
• UDI-Public: (01)10607567106557(10)3000333504(17)260908(11)230908
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K041281
• 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): 04/10/2026

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: 09/08/2026
• Device Model Number: 0684-00-0479-01
• Device Catalogue Number: 0684-00-0479-01
• Device Lot Number: 3000333504
• 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: 04/10/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/08/2023
• 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: CS300
• Patient Sex: Unknown