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 Code	Material Perforation (2205)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during intra aortic balloon (iab) therapy customer identified perforation in balloon.No patient injury or harm was noted.
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).
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h11.Corrected fields: e3.
Additional Manufacturer Narrative
Updated fields: b4, d8, d9, g3, g6, h2, h3, h6 (type of investigation, investigation findings, investigation conclusions), h11.Corrected fields: d1, d4 (version or model #, udi #), e2, e3, e1(initial reporter).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: 22076220
• Report Number: 2248146-2025-0000281
• Device Sequence Number: 9363021
• Product Code: DSP
• UDI-Device Identifier: 10607567107981
• UDI-Public: (01)10607567107981(10)3000282645(17)251127(11)221128
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K120868
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/04/2025

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 Expiration Date: 11/27/2025
• Device Model Number: 0684-00-0295-02
• Device Catalogue Number: 0684-00-0295-02
• Device Lot Number: 3000282645
• 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: 05/10/2025
• Supplement Date Received by Manufacturer: 06/27/2025; 07/04/2025
• Initial Report FDA Received Date: 05/23/2025
• Supplement Report FDA Received Date: 07/03/2025; 07/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/28/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 71 KG