MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD MEGA 7.5FR. 30CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0294-01
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/03/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
Occupation: education coordinator.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
It was reported that after approximately 16 days of intra-aortic balloon (iab) therapy, the pump generated a catheter restriction alarm and a rupture occurred.The insertion was reported to be axillary, which is not the method described in the device instructions for use.The iab was removed.Based upon risks/benefits a new iab was not inserted.The patient expired on (b)(6) 2022.
Additional Manufacturer Narrative
Additional information: lot #, serial #, exp.Date, manufacture date.Device evaluation: the product was returned with the membrane completely unfolded and blood on the interior and exterior of the catheter.The extender tubing was also returned.A kink was observed on the catheter tubing and inner lumen near the y-fitting approximately 76.7cm from iab tip.Additionally two kinks were found on the inner lumen within the membrane approximately 3.8cm and 4.3cm from iab tip.The inner lumen within the membrane was also observed to be stretched near the distal end.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal and extender tubing was performed and two leaks were detected on the membrane approximately (primary abrasion) 1.5cm and (sharp edge) 16cm from the rear seal and measuring (primary abrasion) 0.127cm and (sharp edge) 0.013cm in length.The reported problem was most likely triggered by leaks which was found on the membrane.Under magnification, a whitish patch was observed around the leak.This whitish patch is the typical appearance of an abrasion mark which is caused by calcified plaque in the aorta.The second penetration found on the membrane appears to have been caused by a sharp object.We are unable to determine when this may have occurred.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.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. 30CC 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: 16091456
• Report Number: 2248146-2023-00007
• Device Sequence Number: 12421941
• Product Code: DSP
• UDI-Device Identifier: 10607567107950
• UDI-Public: 10607567107950
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/25/2025
• Device Model Number: 0684-00-0294-01
• Device Catalogue Number: 0684-00-0292
• Device Lot Number: 3000237883
• 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: 12/12/2022
• Supplement Date Received by Manufacturer: 02/28/2023
• Initial Report FDA Received Date: 01/03/2023
• Supplement Report FDA Received Date: 02/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 74 KG