MAUDE Adverse Event Report: Datascope Corp. MEGA 8Fr. 50cc IAB with Accessories, US Only; System, Balloon, Intra-Aortic And Control

Model Number	0684-00-0296-01U
Medical Device Problem Codes	Fluid/Blood Leak (1250); Difficult to Insert (1316); Unraveled Material (1664); Material Perforation (2205)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields b4, d9 device available for evaluation and date return to manufacture, g3, g4 (pma 510k), g6, g7, h2, h3, h6 type of investigation, investigation findings, investigation conclusions, h11 corrected field d7a   revert a1, d4 serial number, d8 should left blank   the iab was returned with the membrane completely unfolded and small traces of blood on the exterior of the catheter.The inner lumen was found occluded with dried blood and was able to be cleared.The sheath was not returned for evaluation.  a laboratory insertion test was unable to be performed due to the membrane being unfurled.  an underwater leak test of the balloon, catheter, y fitting and extracorporeal tubing was performed and no leaks were detected.A leak may impact the ability to maintain vacuum.  the trend review did not identify a trigger of the trend data within the review period.The complaint history review did not identify an adverse trend increase in number of complaints over past three 3 months.  a dhr review was not conducted for this investigation.This complaint is not classified as a death or serious injury, nor did the investigation confirm a manufacturing defect.  we are unable to confirm the reported difficulty during insertion because of the returned condition of the catheter and we are unable to mimic the clinical setting.Per ifu the one way valve must be aspirated to 30cc while leaving the one way valve in place attached to the extracorporeal tubing luer to ensure vacuum is maintained throughout insertion.Additionally, no leaks were found which a leak could have indicated damage to the balloon.

• Brand Name: MEGA 8Fr. 50cc IAB with Accessories, US Only
• 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: 50320527
• Report Number: 2248146-2026-0001418
• Device Sequence Number: 21236287
• Product Code: DSP
• UDI-Device Identifier: 10607567109619
• UDI-Public: (01)10607567109619(10)3000511513(17)281107(11)251107
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K133074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 09/30/2026

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: 0684-00-0296-01U
• Device Catalogue Number: 0684-00-0296-01U
• Device Lot Number: 3000511513
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/06/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/29/2026
• Initial Report FDA Received Date: 08/19/2026
• Supplement Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 221 LB