MAUDE Adverse Event Report: Datascope Corp. MEGA 7.5Fr. 40cc IAB with Accessories, US Only; System, Balloon, Intra-Aortic And Control

Model Number	0684-00-0295-01U
Medical Device Problem Codes	Fluid/Blood Leak (1250); Difficult to Remove (1528); Material Rupture (1546)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) at 08:05, while assisting the patient to the toilet, the bedside registered nurse (rn) observed blood in the intra-aortic balloon pump (iabp) helium line, indicating a suspected mega 40cc intra-aortic balloon (iab) rupture.The respiratory therapist (rt) responded promptly to assess the situation.In accordance with standard practice, the iabp was immediately turned off, and the helium line was clamped to prevent further blood entry into the balloon.A critical care physician attempted to remove the iab catheter; however, significant resistance was encountered during extraction.During the removal attempt, the patient developed stroke-like symptoms, including weakness and headache.Cardiothoracic surgery was consulted and successfully removed the catheter without further complication.Following catheter removal, the patient's neurological symptoms resolved completely.Computed tomography (ct) scans of the head and chest were performed to evaluate for potential complications.Both studies were unremarkable, with no evidence of acute intracranial pathology, vascular injury, or other procedure-related complications.The patient remained hemodynamically stable, and a replacement iab catheter was subsequently inserted.
Event or Problem Description
It was reported that blood was observed in the helium tubing of a mega 40cc intra-aortic balloon (iab) catheter during use, indicating a suspected balloon rupture.Removal of the intra-aortic balloon (iab) catheter was initially unsuccessful due to resistance, and the patient developed transient stroke-like symptoms during the removal attempt.The patient's neurological symptoms resolved completely, imaging was unremarkable, and a replacement intra-aortic balloon (iab) catheter was subsequently inserted.
Additional Manufacturer Narrative
Updated fields: h6, b5, d9, h3, h2, g6 corrected fields: h1, h6, an investigation was conducted regarding blood back, rupture and difficulty in removal of mega 7.5fr.40cc balloon.The evaluation determined an inner lumen break within a kink causing the reported leak.Additionally blood filling inside the iab resulted in difficulty removing the iab from the patient.The evaluation confirmed the reported problem.A lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.This issue continues to be monitored within the manufacturer¿s quality system.
Additional Manufacturer Narrative
Event site name: (b)(6).Initial reporter: (b)(6).Upon completion of the investigation into this event a follow up report will be submitted.

• Brand Name: MEGA 7.5Fr. 40cc 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: 50065656
• Report Number: 2248146-2026-0001331
• Device Sequence Number: 13328237
• Product Code: DSP
• UDI-Device Identifier: 10607567109596
• UDI-Public: (01)10607567109596(10)3000517051(17)281203(11)251203
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K120868
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/08/2026

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 Model Number: 0684-00-0295-01U
• Device Catalogue Number: 0684-00-0295-01U
• Device Lot Number: 3000517051
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/20/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2026
• Supplement Date Received by Manufacturer: 08/12/2026; 09/08/2026
• Initial Report FDA Received Date: 07/29/2026
• Supplement Report FDA Received Date: 09/01/2026; 09/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2025
• 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: Teleflex AC3 Optimus Intra-Aortic Balloon Pump
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 39 YR
• Patient Sex: Male
• Patient Weight: 178 LB