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	Leak/Splash (1354); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to character limit: e1 (event site name): (b)(6) hospital.Nurse called for assistance with a gas loss alarm on a cardiosave during use.She reported that the alarm had gone once before, and she was inquiring about what to do if it went off again.She did utilize the help screen and the iab fill key to restart therapy, but wanted to ensure it was okay because the patient was on his 3rd balloon catheter after having experienced 2 previous perforations (not reported and not available for return; initial placement, 1st exchange, 2nd exchange).Troubleshooting determined the insertion was axillary and she was unsure of the brand of the introducer in use, off label and off brand disclaimers provided.Esp person had (b)(6) verify there was no blood in the helium tubing, all connections were secure and appropriate, and there were no visible kinks in the line.Esp person explained the nature of the alarm and based on the information she gave to esp person regarding the patient hemodynamics and clinical picture, the alarm was potentially caused by movement and the insertion point.Esp person encouraged (b)(6) to call me should the alarm go off several times in an hour so that we could troubleshoot together.
Event or Problem Description
It was reported by the customer via emergency support program line, that the intra aortic balloon (iab) mega 50cch had a gas loss alarm.There were no patient harm or injury was reported.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h11.Corrected fields: h6 (medical device problem code and type of investigation).
Event or Problem Description
N/a.

• 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: 24637439
• Report Number: 2248146-2026-0000791
• Device Sequence Number: 10008809
• Product Code: DSP
• UDI-Device Identifier: 10607567108001
• UDI-Public: (01)10607567108001(10)3000456801(17)280227(11)250227
• Combination Product (Y/N): N
• 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): 04/12/2026

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: 02/25/2026
• Supplement Date Received by Manufacturer: 04/12/2026
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 04/11/2026
• 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: IABP.
• Patient Age: 44 YR
• Patient Sex: Male
• Patient Weight: 102 KG