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

Model Number	0684-00-0295-05
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Embolism/Embolus (4438); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2025
Type of Reportable Event	Death
Event or Problem Description
It was reported that during intra aortic balloon (iab) therapy, after successful puncture, the guidewire broke during the iabp catheter placement.
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).Due to character restrictions in block e1 (b)(6) hospital of (b)(6) university.
Additional Manufacturer Narrative
Updated fields: a4, b1, b2, b4, b5, e1 (initial reporter, event site email), g3, g4 (pma/510k), g6, h1, h2, h6 (health effect impact codes) corrected fields: d4 (version or model, exp.Date, unique identifier), d7a, h4.Due to character limit in block e1 event site address: no.(b)(6).
Event or Problem Description
It was reported that during routine intra-aortic balloon (iab) therapy involving standard disinfection, draping, administration of local lidocaine anesthesia, and seldinger puncture of the right femoral artery, vascular access was successfully obtained.However, during the insertion of the iab catheter, the guidewire fractured.The first iab catheter lumen was noted to be folded, and a replacement balloon was subsequently inserted.Following the placement of the second iab catheter, it was not connected to the intra-aortic balloon pump (iabp).The patient passed away shortly thereafter.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h1, h2, h11.Corrected fields: b1, b5, d4 (exp date and udi), h1, h4, h6 (health effect clinical code and impact code).
Event or Problem Description
It was reported that during routine preparation for intra-aortic balloon pump (iabp) therapy¿including disinfection, draping, administration of local lidocaine anesthesia, and seldinger puncture of the right femoral artery, the guidewire fractured during the placement of the iabp catheter, despite successful puncture.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h11.Corrected fields: b1, b2, b5, h1, h6 (health effect clinical code and impact code).
Event or Problem Description
It was reported that during routine intra-aortic balloon (iab) therapy involving standard disinfection, draping, administration of local lidocaine anesthesia, and seldinger puncture of the right femoral artery, vascular access was successfully obtained.However, during the insertion of the iab catheter, the guidewire fractured.The first iab catheter lumen was noted to be folded, and a replacement balloon was subsequently inserted.Following the placement of the second iab catheter, it was not connected to the intra-aortic balloon pump (iabp).The patient passed away shortly thereafter.
Event or Problem Description
N.A.
Additional Manufacturer Narrative
Updated fields: b4, d9, g1 (contact person mfg site), g3, g6, h2, h3, h6 (type of investigation, investigation findings and investigation conclusions).Corrected field: d10, h6 (health effect clinical 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.
Additional Manufacturer Narrative
Updated fields: b2, b4, g3, g6, h2, h11.Corrected field: h6 (health effect clinical code, type of investigation, component codes).

• Brand Name: MEGA 7.5 FR. 40CC IAB (CHINA)
• 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: 22085767
• Report Number: 2248146-2025-0000287
• Device Sequence Number: 18148359
• Product Code: DSP
• UDI-Device Identifier: 10607567109039
• UDI-Public: (01)10607567109039(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: Physician Assistant
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 08/22/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0684-00-0295-05
• Device Catalogue Number: 0684-00-0295-05
• 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: 05/14/2025
• Supplement Date Received by Manufacturer: 05/27/2025; 06/07/2025; 06/12/2025; 07/23/2025; 08/15/2025
• Initial Report FDA Received Date: 05/27/2025
• Supplement Report FDA Received Date: 05/30/2025; 06/12/2025; 06/13/2025; 07/23/2025; 08/22/2025
• 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: IABP.; UNKNOWN.
• Outcome Attributed to Adverse Event: Death
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 45 KG