MAUDE Adverse Event Report: DATASCOPE CORP. MEGA 7.5 FR. 40CC IAB W/O STATLOCK - INDIA; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0295-07
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to character limit in block e1 event site name is (b)(6).A supplemental report will be submitted upon completion of our investigation.Complaint id#: (b)(4).
Event or Problem Description
It was reported that the intra-aortic balloon (iab) catheter ruptured two days after insertion.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: b4, d9, g3, g6, h2, h3, h6 (type of investigation, investigation findings, component codes and investigation conclusions), h11.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.
Additional Manufacturer Narrative
Updated fields: b4, b5, g1, g3, g6, h6 (health effect ¿ clinical code, health effect ¿ impact codes ), h11.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.
Event or Problem Description
It was reported that the intra-aortic balloon (iab) catheter ruptured two days after insertion, no patient harm or injury reported.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h11.Corrected fields: e1 (initial reporter, event site email).Due to character limitation in block e1: initial reporter: (b)(6).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.

• Brand Name: MEGA 7.5 FR. 40CC IAB W/O STATLOCK - INDIA
• 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: lori gosselin ; 15 law drive; fairfield, NJ 07004
• MDR Report Key: 21854969
• Report Number: 2248146-2025-0000223
• Device Sequence Number: 7888733
• Product Code: DSP
• UDI-Device Identifier: 10607567111339
• UDI-Public: (01)10607567111339(10)3000338689(17)260926(11)230926
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Followup,Followup
• Report Date (Section B): 07/17/2025

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: 09/26/2026
• Device Model Number: 0684-00-0295-07
• Device Catalogue Number: 0684-00-0295-07
• Device Lot Number: 3000338689
• 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: 04/04/2025
• Supplement Date Received by Manufacturer: 05/13/2025; 07/10/2025; 07/17/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 05/20/2025; 07/14/2025; 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/26/2023
• 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.; UNKNOWN.
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 103 KG