MAUDE Adverse Event Report: DATASCOPE CORP. MEGA 7.5FR. 30CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0294-01
Medical Device Problem Codes	Fluid/Blood Leak (1250); Leak/Splash (1354); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to characterization limit e1 initial reporter: (b)(6).The product has been returned to the manufacturer,but is pending investigation.Once the investigation is completed a supplemental report with our findings will be submitted complaint record id (b)(4).
Event or Problem Description
It was reported that the mega 30cc had high pressure, kink alarms a few hours prior to rupture.Blood noted in helium line, console turned off.Blood did not enter console.Catheter removed, no complications noted.No harm or injury to the patient was reported.
Additional Manufacturer Narrative
Updated fields: b4, e1 (event site state, event site postal code), g3, g6, h2, h6 (type of investigation, investigation findings, investigation conclusions), h11 corrected fields: b8, h6 (medical device problem code) revert the contents of section e1 (event site address line 2) to blank keeping 510k blanks as data not available.The iab was returned with the membrane completely unfolded and blood on the interior and exterior of the catheter.The extender tubing was also returned.The extracorporeal tubing was returned separate from the iab catheter.An underwater leak test of the balloon, catheter, y fitting, extracorporeal and extender tubing was performed and a leak was detected on the membrane approximately 1cm from the rear seal measuring 0.013cm in length.The reported problem was most likely triggered by a leak which was found on the membrane.Under magnification, a whitish patch was observed around the leak.This whitish patch is the typical appearance of an abrasion mark which is caused by calcified plaque in the aorta.A lot history record review was completed for the reported product.No non conformances 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).Based on the rational provided above, no escalation to the capa process is required.
Event or Problem Description
N/a.

• Brand Name: MEGA 7.5FR. 30CC IAB
• 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: 24747069
• Report Number: 2248146-2026-0000836
• Device Sequence Number: 9318872
• Product Code: DSP
• UDI-Device Identifier: 10607567107950
• UDI-Public: (01)10607567107950(10)3000354665(17)261208(11)231208
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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
• Report Date (Section B): 04/20/2026

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: 0684-00-0294-01
• Device Catalogue Number: 0684-00-0294-01
• Device Lot Number: 3000354665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2026
• Supplement Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2023
• 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: AC3 OPTIMUS.
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 59 KG