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 Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation : mba, rrt.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
It was reported that after approximately 19 days of intra-aortic balloon (iab) therapy, blood was seen in the tubing while ambulating the patient.The insertion was reported to be axillary, which is not the method described in the device instructions for use.The tubing was clamped and the console was turned off.No alarms were noted.The iab was removed and the physician was notified.A new iab was inserted via the right femoral artery.There was no patient harm or adverse event reported.
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 the inner lumen within the catheter tubing was completely separated within a kink near the y-fitting approximately 76.7cm from iab tip.The inner lumen was found occluded with dried blood.The occlusion was unable to be cleared.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal and pressure tubing was performed and no other leaks were detected.The break found in the inner lumen appears to have been the result of a severe kink, which eventually failed causing the reported problem.It is difficult to determine when the break occurred but it is possibly a result of patient movement during the procedure.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 reported failure.A non-conforming material report 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. - 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: 15266605
• Report Number: 2248146-2022-00639
• Device Sequence Number: 6577285
• 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): 09/28/2022

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: 06/06/2024
• Device Model Number: 0684-00-0295-02
• Device Catalogue Number: 0684-00-0293
• Device Lot Number: 3000175189
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2022
• Supplement Date Received by Manufacturer: 09/28/2022
• Initial Report FDA Received Date: 08/22/2022
• Supplement Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2021
• 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: AUTOCAT 2 WAVE CONSOLE S/N (B)(6)
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 98 KG