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	Leak/Splash (1354); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2022, after approximately 16 days of intra-aortic balloon (iab) therapy, the iab was noted to be high with minimal advancement.The insertion was reported to be axillary, which is not the method described in the device instructions for use.On (b)(6) 2022 23:10, the console generated a high pressure alarm and blood was noted in the extracorporeal tubing.The line was clamped and no blood was in the console.On 1(b)(6) 2022 00:45, the iab was removed and at 10:45 a new iab was inserted.On (b)(6) 2022, an impella device was inserted.Later that day at 21:18, the second iab was removed as it was no longer needed.On (b)(6) 2022, the patient was reported to be stable.There was no patient harm or adverse event reported.
Additional Manufacturer Narrative
The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.Complaint record id # (b)(4).
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The product was returned with the membrane completely unfolded and blood on the interior and exterior of the catheter.A visual examination of the product detected a penetration on the catheter tubing and a inner lumen separation within a kink near the y-fitting approximately 77.2cm from iab tip.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and no other leaks were detected.The penetration found in the catheter tubing and separation in the inner lumen appears to have been caused by a severe kink flexing back and forth that eventually penetrated the tubing causing the reported problems.The insertion was reported to be axillary, which is not the method described in the device instructions for use.This may have contributed to the iab failure.The evaluation confirmed 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).

• 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: 15019557
• Report Number: 2248146-2022-00550
• Device Sequence Number: 19462256
• Product Code: DSP
• UDI-Device Identifier: 10607567107981
• UDI-Public: 10607567107981
• 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
• Report Date (Section B): 08/16/2022

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: 10/04/2024
• Device Model Number: 0684-00-0295-02
• Device Catalogue Number: 0684-00-0293
• Device Lot Number: 3000196784
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2022
• Supplement Date Received by Manufacturer: 08/16/2022
• Initial Report FDA Received Date: 07/14/2022
• Supplement Report FDA Received Date: 08/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2021
• 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.IMPELLA.
• Patient Age: 34 YR
• Patient Sex: Female
• Patient Weight: 89 KG