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); Pacing Problem (1439); Failure to Unfold or Unwrap (1669); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer via emergency support program line, that the mega 50 cc intra aortic balloon (iab) had a gas loss alarm and unable to monitor arterial pressure waveform.There were no patient harm or injury was reported.
Additional Manufacturer Narrative
E1: (b)(6).Alarm catheter restriction indicates that the intra aortic balloon catheter or its associated tubing is restricted preventing normal balloon inflation and deflation.When this alarm occurs the cardiosave system automatically enters standby with the balloon deflated to prevent unsafe pumping until the restriction is resolved.This restriction can result from mechanical obstructions such as kinks or bends in the catheter or tubing, incomplete unfolding of the balloon membrane, or the balloon not fully exiting the sheath during insertion.Off label insertion techniques, like axillary placement, may also increase the risk of catheter restriction.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h11.Corrected fields: h6 (type of investigation, investigation findings, medical device problem code and investigation conclusions).
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: 24567297
• Report Number: 2248146-2026-0000761
• Device Sequence Number: 20928834
• Product Code: DSP
• UDI-Device Identifier: 10607567108001
• UDI-Public: (01)10607567108001(10)2000453789
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2026

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 Model Number: 0684-00-0296-01
• Device Catalogue Number: 0684-00-0296-01
• Device Lot Number: 2000453789
• 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: 02/16/2026
• Supplement Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 04/08/2026
• 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: CARDIOSAVE.
• Patient Age: 40 YR
• Patient Sex: Male
• Patient Weight: 106 KG