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

Model Number	0684-00-0498-01
Medical Device Problem Codes	Leak/Splash (1354); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.Complaint record id # (b)(4).
Event or Problem Description
It was reported that the intra-aortic balloon (iab).The patient presented with acute myocardial infarction, hypotension, and bradycardia.Emergency coronary angiography revealed right coronary occlusion, and one stent was implanted.During and after the procedure, the patient experienced persistent hypotension and was given temporary pacing and intra-aortic balloon counterpulsation (iabp) support.On the first post-procedure day, the patient's blood pressure and heart rate were stable when the iabp machine suddenly alarmed and stopped.The patient was rushed to the bedside, where the iabp extension tube was found to be filled with red, bubbly material, suggesting a ruptured iabp balloon membrane.No harm.
Additional Manufacturer Narrative
Updated fields: b4, d4 (exp date), d9, g3, g6, h2, h3, h4, h6 (type of investigation, investigation findings, component codes and investigation conclusions), h11.Corrected field: d4 (udi and lot), e1 (event site telephone).Due to character limit in block e1 event site telephone: (b)(6).Upon alarm activation and identification of blood like material in the iabp extension tubing, the device was immediately assessed at the bedside.A suspected iabp balloon membrane rupture was identified.To prevent potential complications such as embolism, the catheter was promptly disinfected and removed.The patient was closely monitored following removal, and vital signs remained stable.No further intervention related to the device was required.

• Brand Name: MEGA 8FR. 50CC 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: 23565439
• Report Number: 2248146-2025-0000734
• Device Sequence Number: 15982664
• Product Code: DSP
• UDI-Device Identifier: 10607567107301
• UDI-Public: (01)10607567107301(10)3000469255(17)280414(11)250407
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K133074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2026

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: 0684-00-0498-01
• Device Catalogue Number: 0684-00-0498-01
• Device Lot Number: 3000469255
• 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: 10/23/2025
• Supplement Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 11/16/2025
• Supplement Report FDA Received Date: 01/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/07/2025
• 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: 78 YR
• Patient Sex: Male
• Patient Weight: 75 KG