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

Model Number	0684-00-0295-01
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event site postal code: (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 mega 40cc intra-aortic balloon (iab) was mispackaged as a mega 50cc iab.There was no patient involvement or adverse event reported.
Additional Manufacturer Narrative
No decon or visual inspection performed since product was not returned and could not be evaluated.The image from the facility shows the the iab packaged in the wrong box and confirms the reported problem.A capa was initiated for complaints with iab mispackaged issue, see cr (b)(4).A lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.Reference complaint # (b)(4).

• Brand Name: MEGA 7.5FR. 40CC 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: jingal amin ; 15 law drive; fairfield, NJ 07004
• MDR Report Key: 20334428
• Report Number: 2248146-2024-0000603
• Device Sequence Number: 15860155
• Product Code: DSP
• UDI-Device Identifier: 10607567107974
• UDI-Public: (01)10607567107974(10)3000331567(17)260814(11)260814
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2024

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: 08/14/2026
• Device Model Number: 0684-00-0295-01
• Device Catalogue Number: 0684-00-0295-01
• Device Lot Number: 3000331567
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2024
• Supplement Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 09/30/2024
• Supplement Report FDA Received Date: 11/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/14/2023
• 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: NO PATIENT INVOLVED.
• Patient Sex: Unknown