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 Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to character restrictions in block e1.Event site name: (b)(6).Event site address line 2: (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 id: (b)(4).
Event or Problem Description
It was reported that intra-aortic balloon(iab) first, after implanting a 50cc balloon, the patient was prompted that there was blood in the balloon.After removing it, it was confirmed that there was blood inside the balloon.During the implantation process, it was found that the central cavity of the balloon was folded and could not be successfully implanted into the blood vessel.
Additional Manufacturer Narrative
Updated fields: h6 (type of investigation, investigation findings, component codes, investigation conclusions).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).
Event or Problem Description
It was reported that intra-aortic balloon(iab) first, after implanting a 50cc balloon, the patient was prompted that there was blood in the balloon.After removing it, it was confirmed that there was blood inside the balloon.During the implantation process, it was found that the central cavity of the balloon was folded and could not be successfully implanted into the blood vessel.There was no injury or harm reported to the patient.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: b4, d9, g1(contact person ¿ mfg site), g3, g6, h2, h3, h6 (type of investigation, investigation findings, component codes), h11.The iab was returned with the membrane completely unfolded and traces of blood on the exterior of the catheter.No blood was observed inside the iab catheter.The extender tubing 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 no leaks were detected.The reported event cannot be confirmed by the evaluation.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.The reported event cannot be confirmed by the evaluation.

• 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: 21706620
• Report Number: 2248146-2025-0000181
• Device Sequence Number: 4745587
• Product Code: DSP
• UDI-Device Identifier: 10607567109039
• UDI-Public: (01)10607567109039(10)3000420381(17)271004(11)241004
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K120868
• Number of Events Summarized: 1
• Summary Report (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): 09/26/2025

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: 3000420381
• 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: 03/12/2025
• Supplement Date Received by Manufacturer: 05/07/2025; 09/17/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 05/09/2025; 09/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Unknown