MAUDE Adverse Event Report: Datascope Corp. MEGA 8Fr. 50cc IAB with Accessories, US Only; System, Balloon, Intra-Aortic And Control

Model Number	MEGA 8Fr. 50cc IAB with Accessories, US Only
Medical Device Problem Codes	Fluid/Blood Leak (1250); Difficult to Remove (1528); Material Rupture (1546)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
During an emergency support program call, the customer reported blood in the helium tubing of a cardiosave intra-aortic balloon pump (iabp) while supporting a patient with an axillary-placed mega 8fr.50cc intra-aortic balloon (iab) that had been in place for approximately 30 days.Review of the provided image confirmed blood in the helium tubing, consistent with iab perforation.The patient was also receiving ecmo therapy and was in ct at the time of the call.The customer was advised to immediately discontinue iabp therapy, disconnect the helium tubing from the pump, clamp the extracorporeal tubing, and notify the physician for immediate iab removal.The risks associated with continued therapy and potential iab entrapment were reviewed, and the customer was advised not to resume therapy.The ct rn was contacted to ensure the recommendations were communicated and followed.The patient was subsequently transported to the operating room for iab removal.During the removal procedure, the cardiac surgeon reported difficulty removing the iab and anticipated a surgical cutdown.Device-related information consistent with the ifu was provided, including consideration of arteriotomy if catheter removal was difficult; however, the method of removal and clinical decision-making remained at the discretion of the treating physician.The iab was ultimately being managed surgically.
Additional Manufacturer Narrative
Event site name: (b)(6) this event contains both an adverse event and a product problem.Due to a temporary system limitation associated with recent fda emdr system enhancements, only the adverse event designation could be transmitted in the current submission.Product problem details are included within this report.A supplemental mdr will be submitted once the emdr utility has been updated to support transmission of both event classifications.Upon completion of the investigation into this event a follow up report will be submitted.

• 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: ewelina chorlowska ; 15 law drive; fairfield, NJ 07004
• MDR Report Key: 50517831
• Report Number: 2248146-2026-0001479
• Device Sequence Number: 21502366
• Product Code: DSP
• UDI-Device Identifier: 10607567109619
• UDI-Public: (01)10607567109619(10)3000511513(17)281107(11)251107
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K091449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/31/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: MEGA 8Fr. 50cc IAB with Accessories, US Only
• Device Catalogue Number: 0684-00-0296-01U
• Device Lot Number: 3000511513
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2026
• Initial Report FDA Received Date: 08/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/07/2025
• 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: CARDIOSAVE (IABP) OT1589975, ECMO System.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 178 LB