MAUDE Adverse Event Report: DATASCOPE CORP. MEGA 8FR. 50CC IAB (WITH STATLOCK & APA); SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0296-02
Medical Device Problem Code	Pacing Problem (1439)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to character restrictions in block e1, full event site name is (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
It was reported by customer that during intra aortic balloon (iab) therapy there was an issue with the arterial line quality.The customer was able to aspirate several ccs of blood from the inner lumen of the balloon, however, stated that she could not flush the line.The arterial line tubing had a few ¿extra pieces on the a-line tubing, including a long extension piece and an extra stock cock¿.Customer removed these pieces and attempted to flush again, which was unsuccessful.No patient harm or injury reported.
Additional Manufacturer Narrative
Updated data: b4, g3, g6, h1, h2.Corrected data: h6 (type of investigation).
Additional Manufacturer Narrative
Updated fields - b4, d9, g3, g6, h2, h3, h6 (type of investigation, investigation findings, investigation conclusions), h11.No decon or visual inspection performed since product was not returned and could not be evaluated.(b)(6), an icu nurse, reported an issue with poor arterial line waveform quality using a mega 50 cc balloon on a cardiosave device after femoral insertion.The waveform was flat since the patient¿s arrival.All connections were checked and blood could be aspirated, but the line could not be flushed.Extra tubing components (an extension and a stopcock) were found and removed, but flushing was still unsuccessful.A chest x-ray was recommended to check catheter tip position.After a physician manipulated the balloon, the waveform normalized and the issue was resolved.No patient harm occurred.Based on the event description, the catheter was not in the optimum position to achieve a waveform.The physician had manipulated the balloon and they now had achieved proper waveform.
Event or Problem Description
N/a.

• Brand Name: MEGA 8FR. 50CC IAB (WITH STATLOCK & APA)
• 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: 22727847
• Report Number: 2248146-2025-0000461
• Device Sequence Number: 18228816
• Product Code: DSP
• UDI-Device Identifier: 10607567108018
• UDI-Public: (01)10607567108018(10)3000429587(17)271030(11)241030
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/30/2025

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: 0684-00-0296-02
• Device Catalogue Number: 0684-00-0296-02
• Device Lot Number: 3000429587
• 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: 07/24/2025
• Supplement Date Received by Manufacturer: 09/24/2025; 09/30/2025
• Initial Report FDA Received Date: 08/06/2025
• Supplement Report FDA Received Date: 09/29/2025; 09/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/30/2024
• 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: CARDIOSAVE
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 101 KG