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

Model Number	0684-00-0498-01
Medical Device Problem Codes	Leak/Splash (1354); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
It was reported that during use, the intra-aortic balloon ruptured.There was no harm to the patient.
Additional Manufacturer Narrative
Updated fields: b4, d9, e1 (initial reporter), g3, g6, h2, h3, h6 (type of investigation, investigation findings and investigation conclusions), h11 corrected field: h6 (medical device problem code) due to character limit in block e1 telephone number : (b)(6).The issue was resolved by immediately discontinuing the use of the intra aortic balloon pump as soon as the balloon rupture was identified, thereby preventing any further risk to the patient.The ruptured intra aortic balloon catheter was promptly removed and replaced with a new catheter and appropriate accessories to restore the intended counterpulsation support.Throughout the incident, the patient was closely monitored, and vital signs remained stable with no deterioration in clinical condition.Causes: iab leaks can result from the following cases: 1.Membrane perforations caused by: abrasions tears (penetration by sharp objects).2.Catheter perforations sharp objects.Severe kinks.3.Inner lumen breaks or kinks.4.Tip leaks.5.Rear seal leaks.
Event or Problem Description
N/a.

• Brand Name: MEGA 8FR. 50CC 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: 24414040
• Report Number: 2248146-2026-0000715
• Device Sequence Number: 10605214
• Product Code: DSP
• UDI-Device Identifier: 10607567107301
• UDI-Public: (01)10607567107301(10)3000467585(17)280407(11)250407
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K133074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2026

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: 0684-00-0498-01
• Device Catalogue Number: 0684-00-0498-01
• Device Lot Number: 3000467585
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2026
• Supplement Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 02/23/2026
• Supplement Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/07/2025
• 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: UNKNOWN.
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 75 KG