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 Codes	Obstruction of Flow (2423); Optical Obstruction (3002)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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
The complaint was received through a direct call from the customer (registered nurse) to the emergency support program.It was reported that while using mega 50cc intra aortic balloon (iab), the reporter called for assistance for a clotted inner lumen on a non fiberoptic balloon catheter via axillary insertion.No harm or injury to the patient was reported.

• 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: 25066149
• Report Number: 2248146-2026-0000979
• Device Sequence Number: 13210908
• Product Code: DSP
• UDI-Device Identifier: 10607567108001
• UDI-Public: (01)10607567108001(10)3000456801(17)280227(11)250227
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2026

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: 3000456801
• 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: 04/14/2026
• Supplement Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 05/04/2026
• Supplement Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/27/2025
• 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: IABP
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 91 KG