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 Codes	Inability to Auto-Fill (1044); Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: medical director, cardiologist.Event site postal code: (b)(6).The device has not been returned to the manufacturer so we are unable to complete an evaluation.Reference complaint # (b)(4).
Event or Problem Description
It was reported that the intra-aortic balloon (iab) was difficult to insert.Once the iab reached the descending aorta and the helium line was connected, the iab was unable to fill and initiated an autofill failure alarm.After repeated attempts, the introducer was changed to an 8fr and the iab was replaced to provide therapy.There was no patient harm or adverse event reported.
Additional Manufacturer Narrative
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).
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Providing updated device identification information in alignment with gudid.Device evaluation: the product was returned with the membrane completely unfolded and blood on the exterior of the catheter.Two kinks were observed on the catheter tubing approximately 76.7cm and 74.9cm from the iab tip.The inner lumen was found to be occluded.The occlusion was unable to be cleared.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal tubing performed and a leak was detected on the catheter tubing approximately 64.Cm from the iab tip.The reported problem of ¿alarm, autofill failure¿ was most likely triggered by the leak found on the catheter tubing.The penetration found on the catheter tubing appears to have been caused by a sharp object.We are unable to determine when this may have occurred.We are unable to confirm the reported difficulty during insertion because of the returned condition of the catheter and we are unable to mimic the clinical setting.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).
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 07004
• Manufacturer (Section G): DATASCOPE CORP.; 15 law drive; fairfield NJ 07004
• Manufacturer Contact: brian schaeffer ; 15 law drive; fairfield, NJ 07004
• MDR Report Key: 18991298
• Report Number: 2248146-2024-00181
• Device Sequence Number: 16903611
• Product Code: DSP
• UDI-Device Identifier: 10607567107974
• UDI-Public: (01)10607567107974(10)3000338689(17)260926(11)230926
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/22/2024

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: 09/26/2026
• Device Model Number: 0684-00-0295-01
• Device Catalogue Number: 0684-00-0295-01
• Device Lot Number: 3000338689
• 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: 03/08/2024
• Supplement Date Received by Manufacturer: 04/23/2024; 05/31/2024; 10/22/2024
• Initial Report FDA Received Date: 03/28/2024
• Supplement Report FDA Received Date: 05/08/2024; 05/31/2024; 10/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2023
• 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: UNKNOWN.
• Patient Age: 82 YR
• Patient Sex: Unknown