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	06/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: nurse manager, event site postal code: 308433.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) h3 other text: device not returned.
Event or Problem Description
It was reported that the nurse manager noticed an error in the quantity of intra-aortic balloons (iab) that were delivered.They had ordered d684-00-0295-01 mega 40cc x 5pcs and d684-00-0296-01mega 50cc x 5pcs but d684-00-0295-01 mega 40cc x 4pcs and d684-00-0296-01mega 50cc x 6pcs were delivered instead.The products were returned back to the getinge warehouse for investigation as the inventory in the system tallies with the quantity that was ordered and delivered.Upon investigating the products that were returned on 7 june 2024, the logistic team realized that one of the d684-00-0295-01 mega 40cc was wrongly labelled.The mega 40cc was packed in a 50cc shelf carton, instead of a 40 cc shelf carton.There was no patient involvement or adverse event reported.
Additional Manufacturer Narrative
Device evaluation: the iab, pouch, and insertion kit were returned in their original packaging and were unused by the customer.All components were present and undamaged.However, upon checking the packaging carton, it was noted that the artwork on the outer carton does not correspond with the balloon size of the device inside the box.-the returned product was visually inspected and discovered to have an outer carton labeled incorrectly; it was marked as mega fr8 50cc instead of mega fr7.5 40cc.The iab was found to be mispackaged, confirming the reported problem.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).
Additional Manufacturer Narrative
Updated fields: b4, d8, g1 (contact person ¿ mfg site), g3, g6, g7, h2, h11.Corrected fields: h6 ( investigation conclusions).Reference complaint no.(b)(4).
Event or Problem Description
N/a.

• 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
• Manufacturer (Section G): DATASCOPE CORP.; 15 law drive; fairfield NJ 07004
• Manufacturer Contact: henry pena ; 15 law drive; fairfield, NJ 07004
• MDR Report Key: 19620095
• Report Number: 2248146-2024-00395
• Device Sequence Number: 20441511
• Product Code: DSP
• UDI-Device Identifier: 10607567107974
• UDI-Public: (01)10607567107974(10)3000331567(17)260814(11)230814
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/10/2025

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: 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2024
• Supplement Date Received by Manufacturer: 09/04/2024; 03/05/2025
• Initial Report FDA Received Date: 06/26/2024
• Supplement Report FDA Received Date: 09/05/2024; 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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