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

Model Number	0684-00-0295-02
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: (b)(6) care services.Additional reporter(s): dr.(b)(6) / dr.(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).H3 other text : device not returned.
Event or Problem Description
It was reported that the intra-aortic balloon (iab) was inserted on (b)(6) 2023 at 15:58.On (b)(6) 2023 at 12pm an excessive build up of clear fluid was noted in the extracorporeal helium line.No blood specs were noted in the tubing.The insertion was reported to be axillary, which is not the method described in the device instructions for use.The arterial augmentation was good and the waveform was appropriate.The provider was notified and the decision was made to keep the iab in place until the patient could receive an left ventricular assist device (lvad) as the patient was dependent on iab therapy.Therapy was continued and the patient later received an lvad.The iab was removed on (b)(6) 2023 at 6:16am.There was no patient harm or adverse event reported.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The product was returned with the membrane completely unfolded and blood on the exterior of the catheter.The extender and pressure tubing were also returned.No blood was observed inside the iab catheter.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal, extender and pressure tubing was performed and no leaks were detected.The reported event cannot be confirmed by the evaluation.The insertion was reported to be axillary, which is not the method described in the device instructions for use.This may contribute to iab complications during use.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
Additional reporter information: (b)(6).
Event or Problem Description
N/a.
Additional Manufacturer Narrative
**udi related data quality updates only** providing updated device identification information in alignment with gudid complaint record id # (b)(4).

• Brand Name: MEGA 7.5FR. 40CC IAB (WITH APA)
• 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
• Manufacturer Contact: brian schaeffer ; 15 law drive; fairfield, NJ
• MDR Report Key: 18357580
• Report Number: 2248146-2023-00719
• Device Sequence Number: 17873503
• Product Code: DSP
• UDI-Device Identifier: 10607567107981
• UDI-Public: (01)10607567107981(10)3000305236(17)260320(11)230321
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K120868
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/26/2024

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: 03/20/2026
• Device Model Number: 0684-00-0295-02
• Device Catalogue Number: 0684-00-0295-02
• Device Lot Number: 3000305236
• 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: 11/29/2023
• Supplement Date Received by Manufacturer: 12/26/2023; 01/26/2024; 08/26/2024
• Initial Report FDA Received Date: 12/19/2023
• Supplement Report FDA Received Date: 01/09/2024; 01/26/2024; 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2023
• 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: AC3 OPTIMUS CONSOLE
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 65 KG