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

Model Number	0684-00-0295-02
Medical Device Problem Codes	Difficult to Insert (1316); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during insertion of the intra-aortic balloon(iab), the guidewire was bent and it wasn't possible to insert.Another guidewire was used to start insertion of the iab.There was no reported injury or adverse event to the patient.
Additional Manufacturer Narrative
Complete event site name - (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).
Additional Manufacturer Narrative
Updated fields: patient information, device available for eval updated from yes to no, health professional updated to yes, occupation-nurse.Reference complaint #(b)(4).
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The device has not been returned to the manufacturer so we are unable to complete an evaluation.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. - FAIRFIELD; 15 law drive; fairfield NJ
• Manufacturer (Section G): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ
• Manufacturer Contact: brian schaeffer ; 15 law drive; fairfield, NJ
• MDR Report Key: 16015407
• Report Number: 2248146-2022-00999
• Device Sequence Number: 6503081
• Product Code: DSP
• UDI-Device Identifier: 10607567107981
• UDI-Public: 10607567107981
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/06/2023

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: 01/31/2025
• Device Model Number: 0684-00-0295-02
• Device Catalogue Number: 0684-00-0293
• Device Lot Number: 3000219437
• 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: 12/08/2022
• Supplement Date Received by Manufacturer: 01/11/2023; 04/06/2023
• Initial Report FDA Received Date: 12/20/2022
• Supplement Report FDA Received Date: 01/23/2023; 04/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2022
• 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.
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 80 KG