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

Model Number	0684-00-0296-02
Medical Device Problem Codes	Leak/Splash (1354); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that intra aortic balloon had balloon rupture.No alarms prior to rupture.No harm or injury to the patient was reported.
Additional Manufacturer Narrative
Due to characterization limit e1: initial reporter: (b)(6).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
N/a.
Additional Manufacturer Narrative
Updated fields: b4, d4, expiry date, d9.Device available for evaluation and date return to manufacture: g3, g6, h2, h3, h4, h6, type of investigation, investigation findings, investigation conclusions h11.Corrected field d4 lot and udi number: 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 inner lumen was found occluded with dried blood the occlusion was unable to be cleared.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 15cm from the rear seal measuring 0025cm 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 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 nonconforming 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.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h11 corrected fields: d10, and h6 (medical device problem code).
Event or Problem Description
N/a.

• Brand Name: MEGA 8FR. 50CC IAB (WITH STATLOCK & APA)
• 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: 24276436
• Report Number: 2248146-2026-0000665
• Device Sequence Number: 9926703
• Product Code: DSP
• UDI-Device Identifier: 10607567108018
• UDI-Public: (01)10607567108018(10)3000457923(17)280306(11)250306
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 03/30/2026

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: 0684-00-0296-02
• Device Catalogue Number: 0684-00-0296-02
• Device Lot Number: 300457923
• 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: 01/15/2026
• Supplement Date Received by Manufacturer: 03/12/2026; 03/30/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 03/13/2026; 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2025
• 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: PUMP
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 86 KG