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

Model Number	0684-00-0296-01
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the intra-aortic balloon therapy, the balloon ruptured.No harm or injury was reported.
Additional Manufacturer Narrative
Due to character restrictions, event site name: (b)(6).Device has not been returned to manufacturer, supplemental report will be submitted upon completion of additional findings.Complaint id: (b)(4).
Additional Manufacturer Narrative
Updated fields - b4, g3, g6, h2, h11.Corrected fields - h1.
Event or Problem Description
N/a.
Event or Problem Description
It was reported that during the intra-aortic balloon therapy, the mega 50cc balloon ruptured.The removal of the r femoral iabp required a femoral cutdown by vascular surgery and repair of arteriotomy.
Additional Manufacturer Narrative
Additional event site telephone (b)(6).Updated fields - b4, d1(exp date), d9, g3, g6, h2, h3,h6 (type of investigation, investigation findings, component codes, investigation conclusion), h11.Corrected fields - b1, b2, b5, d1(brand name), d7a, g4(pma/510k), h6(health effect ¿ clinical code and health effect ¿ impact codes).The product was returned with the membrane completely unfolded and blood on the exterior and interior of the membrane and catheter.No occlusion was found inside of the inner lumen.The one-way valve was also returned.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal tubing and one way valve was performed and three leaks were detected on the membrane approximately 14.5, 13.2 and 11cm from the iab tip measuring 0.03in/0.076cm, 0.005in/0.01cm and 0.02in/ 0.051cm length.The reported problems were most likely triggered by three leaks which were found on the membrane.The leak appearance suggests that a sharp object may have caused it, condensation may appear around the leak site from the air and water during the leak test preformed.A lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.The failure mode is addressed in the risk file and is operating within its risk profile.The ifu addresses the reported failure.There were no ncmrs identified which could cause or contribute to the reported failure.The investigation does not indicate that the device was inadvertently released as non-conforming or an adulterated product or was a counterfeit.The complaint history review did not identify an adverse trend (increase in number of complaints over past three (3) months).Reference complaint - (b)(4).

• Brand Name: MEGA 8FR. 50CC IAB (WITH STATLOCK)
• 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: 23413963
• Report Number: 2248146-2025-0000668
• Device Sequence Number: 10431748
• Product Code: DSP
• UDI-Device Identifier: 10607567108001
• UDI-Public: (01)10607567108001(10)3000453789(17)280217(11)250217
• Combination Product (Y/N): N
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/12/2025

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: 0684-00-0296-01
• Device Catalogue Number: 0684-00-0296-01
• Device Lot Number: 3000453789
• 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: 10/07/2025
• Supplement Date Received by Manufacturer: 12/04/2025; 12/12/2025
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 12/10/2025; 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2025
• 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.; UNKNOWN.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 29 YR
• Patient Sex: Male
• Patient Weight: 88 KG