MAUDE Adverse Event Report: DATASCOPE CORP. MEGA 8FR. 50CC IAB (WITH STATLOCK); SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0296-01
Medical Device Problem Codes	Restricted Flow rate (1248); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Gas loss in iab circuit occurs when helium loss is detected due to leaks or high diffusion.Alarm triggers if cumulative loss is greater than 5 cc per hour and inflation 80 ms or greater and deflation 250 ms or greater.Causes 1.Loose luer or connector connections 2.Off label use.
Event or Problem Description
(b)(6) an icu rn, called into the emergency support program line requesting instructions to print an alarm and trigger log.Esp personnel provided the steps and she successfully printed the requested log.She reviewed the alarm log and stated the last two alarms were catheter restriction and gas loss.There was no current alarm at the time of the call.Esp personnel reviewed the nature of both alarms and the proper troubleshooting for each.(b)(6) verified there was no blood, discoloration, or flakes in the helium tubing and that all connections were secured.She reported the patient had an axillary inserted balloon catheter.An axillary disclaimer was provided.Esp personnel and (b)(6) reviewed probable causes that could trigger both of those alarms.No patient harm or injury was reported.

• Brand Name: MEGA 8FR. 50CC IAB (WITH STATLOCK)
• 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: 24785011
• Report Number: 2248146-2026-0000850
• Device Sequence Number: 12278017
• Product Code: DSP
• UDI-Device Identifier: 10607567108001
• UDI-Public: (01)10607567108001(10)3000456801(17)280227(11)250227
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2026

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: 0684-00-0296-01
• Device Catalogue Number: 0684-00-0296-01
• Device Lot Number: 3000456801
• 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: 03/13/2026
• Supplement Date Received by Manufacturer: 05/06/2026
• Initial Report FDA Received Date: 04/04/2026
• Supplement Report FDA Received Date: 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/27/2025
• 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 Age: 40 YR
• Patient Sex: Male
• Patient Weight: 32 KG