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 Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields:b1,b4,b7,d8,g3,g6,g7,h2,h6(type of investigation, investigation findings,component codes, investigation conclusions),h11 corrected fields: d4(udi),d10,h4 additional contact info:(b)(6) please revert the a1(patient id),d8 field to blank product was not returned so an exact cause of the issue could not be identified.However, based on our investigation, difficult or unable to insert through sheath occur due to one or more of the following probable causes.The failure mode difficult or unable to insert iab through sheath occurs when the intra aortic balloon catheter cannot be smoothly advanced through the supplied introducer sheath.This may involve increased resistance, halted progression, or complete blockage.The issue can compromise appropriate iab placement, delay therapy, or require device replacement.Potential causes insertion difficulty can result from abnormalities in either the sheath or catheter, including sheath related causes kinked or bent sheath unfolded sheath clotted sheath incorrect sheath size damaged sheath hub catheter lumen related causes broken inner lumen inner lumen kink catheter kink.Unfolded membrane.

• 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: 50927781
• Report Number: 2248146-2026-0001576
• Device Sequence Number: 21522438
• Product Code: DSP
• UDI-Device Identifier: 10607567107301
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K133074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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: 3000469255
• 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: 09/08/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/14/2025
• 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: IAB.
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 143 LB