MAUDE Adverse Event Report: DATASCOPE CORP. MEGA 7.5 FR. 40CC IAB (CHINA); SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0295-05
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354); Failure to Pump (1502)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event site telephone number exceeds character limit.The event site telephone number is (b)(6).A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that ballon catheter intra-aortic balloon (iab) could not inflate fully when connected to the console.The console was not working normally.
Event or Problem Description
It was reported that ballon catheter intra-aortic balloon (iab) could not inflate fully when connected to the console.The console was not working normally.No harm reported.
Additional Manufacturer Narrative
Updated fields - b4, b5, d9, g3, g6, h2, h3, h6 (health effect ¿ clinical codes, health effect ¿ impact codes,type of investigation, investigation conclusions), h11 corrected field: d7a.No decon or visual inspection performed since product was not returned and could not be evaluated.Therefore, we were unable to confirm or determine a root cause for the reported failure.The failure mode is addressed in the risk file and is operating within its risk profile.The ifu addresses the reported failure.There were no ncmrs identified which could cause or contribute to the reported failure.The investigation does not indicate that the device was inadvertently released as non-conforming or an adulterated product or was a counterfeit.The complaint history review did not identify an adverse trend (increase in number of complaints over past three (3) months).Based on the rational provided above, no escalation to the capa process is required.Complaint id#(b)(4).
Additional Manufacturer Narrative
Updated fields: b4, d8, d9, g1 (contact person mfg site), g3, g6, h2, h3, h6 (type of investigation, investigation findings and investigation conclusions), h11 corrected field: h6 (medical device problem code).The iab was returned with the membrane completely unfolded and blood on the exterior of the catheter.The extender tubing, one-way valve and insertion components were also returned.The pressure tubing was returned unused.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal and extender tubing was performed and two leaks were detected at the same location on the membrane approximately 12.2cm from the rear seal measuring 0.025cm in length.The reported problem was most likely triggered by a leak which was found on the membrane.The penetrations found on the membrane appears to have been caused by a sharp object.The evaluation confirmed the reported problem.A lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.The failure mode is addressed in the risk file and is operating within its risk profile.The ifu addresses the reported failure.There were no ncmrs identified which could cause or contribute to the reported failure.The investigation does not indicate that the device was inadvertently released as non-conforming or an adulterated product or was a counterfeit.The complaint history review did not identify an adverse trend (increase in number of complaints over past three (3) months).Based on the rational provided above, no escalation to the capa process is required.
Event or Problem Description
N/a.

• Brand Name: MEGA 7.5 FR. 40CC IAB (CHINA)
• 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: 21301073
• Report Number: 2248146-2025-0000057
• Device Sequence Number: 8084020
• Product Code: DSP
• UDI-Device Identifier: 10607567109039
• UDI-Public: (01)10607567109039(10)3000396583(17)270611(11)240611
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K120868
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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,Followup
• Report Date (Section B): 09/15/2025

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: 0684-00-0295-05
• Device Catalogue Number: 0684-00-0295-05
• Device Lot Number: 3000396583
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2025
• Supplement Date Received by Manufacturer: 03/21/2025; 09/03/2025
• Initial Report FDA Received Date: 02/04/2025
• Supplement Report FDA Received Date: 03/24/2025; 09/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2024
• 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: 74 YR
• Patient Sex: Male
• Patient Weight: 68 KG