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	05/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to characterization limit e1 event site telephone: (b)(6).Due to characterization limit e1 event site name: (b)(6).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 mega 50cc had triggering a blood leakage alarm issue.Catheter rupture could lead to treatment failure and equipment damage.No harm or injury to the patient was reported.
Additional Manufacturer Narrative
Updated fields: b4, d9, g3, g6, h2, h3, h6 (type of investigation, investigation findings, component codes and investigation conclusions), h11.Corrected field: d4 (lot and udi), d10.Upon activation of the blood leakage alarm indicating a suspected iabp balloon rupture, iabp therapy was immediately discontinued.The affected iabp catheter was promptly removed at 22:00 on may 27th to prevent potential complications.A new iabp cannula was subsequently reinserted at 11:30 on may 28th, and therapy was resumed.The patient was closely monitored, and no adverse effects were observed following reinsertion.

• 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: 23803291
• Report Number: 2248146-2025-0000841
• Device Sequence Number: 12689796
• Product Code: DSP
• UDI-Device Identifier: 10607567107301
• UDI-Public: (01)10607567107301(10)3000431112(17)271202(11)241202
• 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: 3000431112
• 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: 11/25/2025
• Supplement Date Received by Manufacturer: 01/25/2026
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 01/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/02/2024
• 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: 79 YR
• Patient Sex: Male
• Patient Weight: 80 KG