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	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 by the customer that the intra-aortic balloon (iab) had a clotted iab lumen after insertion.There was no patient harm reported.
Additional Manufacturer Narrative
Updated fields - b4, d9, g3, g6, h2, h3, h6 (type of investigation, investigation findings, component code, investigation conclusions), h11.Corrected filed: d4 lot number, udi number.It was reported by the customer that the intra-aortic balloon (iab) had a clotted iab lumen after insertion.There was no patient harm reported.
Event or Problem Description
N/a.

• 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: 23798897
• Report Number: 2248146-2025-0000836
• Device Sequence Number: 8954287
• Product Code: DSP
• UDI-Device Identifier: 10607567108001
• UDI-Public: (01)10607567108001(10)3000501742(17)280918(11)250918
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Report Date (Section B): 01/22/2026

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: 0684-00-0296-01
• Device Catalogue Number: 0684-00-0296-01
• Device Lot Number: 3000501742
• 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: 11/20/2025
• Supplement Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 12/14/2025
• Supplement Report FDA Received Date: 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/18/2025
• 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 Sex: Unknown