MAUDE Adverse Event Report: DATASCOPE CORP. MEGA 7.5FR. 40CC IAB (WITH APA); SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0295-02
Medical Device Problem Codes	Device Alarm System (1012); Difficult to Advance (2920); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported on patient using that intra aortic balloon (iab) the puncture process failed and air leakage occurred.There was no patient harm and injury reported.
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.Complaint id: (b)(4).
Event or Problem Description
It was reported by customer that while performing femoral artery puncture during intra aortic balloon (iab) therapy on a patient using a balloon catheter, the puncture process was not smooth and air leakage occurred.After the puncture failed, the doctor immediately replaced the disposable puncture needle and successfully inserted the balloon.There were no casualties and no machine malfunctions in this incident.
Additional Manufacturer Narrative
Updated fields: b4, d9, g3, g6, h2, h6 (type of investigation , investigation findings, investigation conclusions), h11.Corrected fields: b5, d4 (exp date, udi #, h4, h6 (medical device ¿ problem code).No decon or visual inspection performed since product was not returned and could not be evaluated.Therefore, we were unable to confirm or determine a root cause for the reported failure.Complaint id: (b)(4).

• Brand Name: MEGA 7.5FR. 40CC IAB (WITH APA)
• 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: henry pena ; 15 law drive; fairfield, NJ 07004
• MDR Report Key: 22001009
• Report Number: 2248146-2025-0000267
• Device Sequence Number: 7313686
• Product Code: DSP
• UDI-Device Identifier: 10607567107981
• UDI-Public: (01)10607567107981(10)3000435748(17)271211(11)241211
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K120868
• 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): 06/30/2025

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: 0684-00-0295-02
• Device Catalogue Number: 0684-00-0295-02
• Device Lot Number: 3000435748
• 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: 04/29/2025
• Supplement Date Received by Manufacturer: 06/27/2025
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/11/2024
• 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: UNKNOWN.
• Patient Age: 81 YR
• Patient Sex: Female