MAUDE Adverse Event Report: DATASCOPE CORP. MEGA 8FR. 50CC IAB WITH ACCESSORIES, US ONLY; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0296-01U
Medical Device Problem Codes	Material Deformation (2976); Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that immediately after inserting the intra-aortic balloon (iab), the console generated an alarm and it was noted that the aortic pressures were reading high on console.The md "re-adjusted iab", determined it was kinked, and replaced it with a new one.The iab was in use for approximately 53 minutes before removal.There was no patient harm or adverse event reported.
Additional Manufacturer Narrative
Initial report occupation: cardiac cath lab administrative assistant.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).
Additional Manufacturer Narrative
Updated fields: brand name, unique identifier (udi) #, version or model #, catalog #, pma/510(k)#./ device evaluation: the product was returned with the membrane completely unfolded and blood on the exterior of the catheter.The sheath was returned over the membrane.One kink was observed on the catheter tubing approximately 42.4cm from the iab tip.The extender tubing and dilator were also returned.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal tubing and extender tubing was performed, and no leaks were detected.The iab was placed on the cardiosave pump and pumped for two hours which represents one complete autofill cycle.The iab pumped normally, and no alarm sounded from the pump.The reported event of a kink was confirmed by the evaluation.However, the reported event of ¿alarm, unknown & difficult/ unable to monitor pressure¿ cannot be confirmed by the evaluation.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 8FR. 50CC IAB WITH ACCESSORIES, US ONLY
• 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: 20022108
• Report Number: 2248146-2024-00503
• Device Sequence Number: 20982858
• Product Code: DSP
• UDI-Device Identifier: 10607567109619
• UDI-Public: (01)10607567109619(17)3000308474(10)260502(11)230502
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K133074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2024

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: 05/02/2026
• Device Model Number: 0684-00-0296-01U
• Device Catalogue Number: 0684-00-0296-01U
• Device Lot Number: 3000308474
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2024
• Supplement Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 08/21/2024
• Supplement Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 91 KG