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 Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
After inserting two mega 8 fr 50cc iab catheters in the same patient, the user encountered the following alarms on the cardiosave iabp: "check iab catheter" and "leak in iab system." as a result, therapy could not be initiated, and the patient¿s circulatory support had to be managed with alternative medications.While both alarms are catheter-related, a service technician had inspected the cardiosave iabp earlier that day and found no malfunctions.This suggests that the issue is likely with the iab catheters rather than the pump itself.
Additional Manufacturer Narrative
Updated fields: b4, d8, d9, g3, g6, h2, h3, h6 (type of investigation, investigation findings, component codes and investigation conclusions), h11.The product was returned with the membrane completely unfolded and blood on the exterior of the catheter and in the inner lumen.Two kinks were observed on the catheter tubing approximately 76.7cm and 75.4cm from the iab tip.An underwater leak test of the balloon, catheter, y-fitting, and extracorporeal tubing was performed, and no leaks were detected.The iab was placed on the cardiosave pump, and a gas loss alarm sounded from the pump while the iab was pumping resulting on stopping the pumping immediately.The reported events of "alarm, leak in iab circuit & alarm, check iab catheter " cannot be confirmed by the evaluation.However, the reported failure of kink was confirmed by the evaluation and an analyzed failure of "alarm, gas loss" was found during the investigation.A lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.

• 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: henry pena ; 15 law drive; fairfield, NJ 07004
• MDR Report Key: 21718258
• Report Number: 2248146-2025-0000185
• Device Sequence Number: 18514638
• Product Code: DSP
• UDI-Device Identifier: 10607567109619
• UDI-Public: (01)10607567109619(10)3000382865(17)270422(11)240422
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K133074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 05/12/2025

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 Model Number: 0684-00-0296-01U
• Device Catalogue Number: 0684-00-0296-01U
• Device Lot Number: 3000382865
• 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: 03/17/2025
• Supplement Date Received by Manufacturer: 05/09/2025
• Initial Report FDA Received Date: 03/28/2025
• Supplement Report FDA Received Date: 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2024
• 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: UNKNOWN.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 80 KG