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

Model Number	0684-00-0295-01
Medical Device Problem Codes	Leak/Splash (1354); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after inserting the intra-aortic balloon (iab), the console generated a gas loss in iab circuit alarm for a possible helium leak.The insertion was reported to be axillary, which is not the method described in the device instructions for use.No blood was found in the helium tubing.There was a possibility of a kink in the iab or leakage problem from the console.The iab was removed after a few hours of therapy.There was no patient harm or adverse event reported.
Additional Manufacturer Narrative
Initial reporter occupation: ltd.Perfusionist event site postal code: (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).
Event or Problem Description
N/a.
Additional Manufacturer Narrative
A photograph was provided by the facility.The photograph shows a gas leak alarm.The product was returned with the membrane completely unfolded and blood on the exterior of the catheter and between the catheter and the sheath.The sheath was returned over the catheter tubing.The extracorporeal tubing was cut 1.9cm from the y-fitting.The cut portion of the extracorporeal tubing was not returned.A kink was observed on the catheter tubing approximately 52.1cm from the iab tip.The inner lumen was observed to be occluded.The occlusion was unable to be cleared.An underwater leak test of the balloon, catheter, y-fitting, and extracorporeal tubing was performed and no leaks were detected.Due to the returned condition of the extracorporeal tubing, the iab is unable to be placed on the pump.Based on the photographic evidence provided by the facility, the gas loss alarm is confirmed.However we cannot duplicate the reported alarm due to the returned state of the device.The condition of the iab as received indicated a kink in the catheter tubing.It is difficult to determine when or how a kink in the catheter occurs.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 kink.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: 16715742
• Report Number: 2248146-2023-00256
• Device Sequence Number: 12578774
• Product Code: DSP
• UDI-Device Identifier: 10607567107974
• UDI-Public: 10607567107974
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2023

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: 11/08/2025
• Device Model Number: 0684-00-0295-01
• Device Catalogue Number: 0684-00-0293
• Device Lot Number: 3000279117
• 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: 03/23/2023
• Supplement Date Received by Manufacturer: 06/05/2023
• Initial Report FDA Received Date: 04/11/2023
• Supplement Report FDA Received Date: 06/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2022
• 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: ARROW PUMP.
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 74 KG