MAUDE Adverse Event Report: DATASCOPE CORP. SENSATION 7FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0470-01
Medical Device Problem Codes	Difficult to Flush (1251); Difficult to Insert (1316); Obstruction of Flow (2423); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 during intra-aortic balloon (iab) therapy, the first balloon has been switched with second balloon which also had a bit of difficulty in aspirating and infusing but it is decided to continue the therapy.However, the balloon worked without problems even with the line not washing correctly, it will then be removed after bypass surgery.No harm to the patient.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields - b4, g3, g6, h2, h6 (health effect ¿ clinical code), h11 corrected field - e1 (initial reporter) initially in e1 field initial reporter should be blank as there is no information.
Additional Manufacturer Narrative
Updated fields - b4, d4 expiry date, d9, g3, g6, h2, h3, h4, h6 (type of investigation, investigation findings, component code, investigation conclusions), h11 corrected field: d4 lot number udi number, h6 medical device problem code balloon is inserted under angiographic guidance, already during insertion of the 0.018 guide inside the baloon the customer feels more difficulty than usual, once the guide has been removed the customer is preparing to aspirate and wash the balloon, but nothing came from the washing line, aspiration with a 50cc syringe is difficult and infusion practically impossible.In agreement with the doctor, it is decided to go back up with the guide, with difficulty they manage to go up again, but in any case no patency in aspiration after the guide has been removed.So it is decided to change the balloon, where the guide climbs well, the insertion and positioning always under the guide occurs without problems, but a bit of difficulty in aspirating and infusing is still recorded, but it is decided to continue the therapy.However, the balloon will work without problems even with the line not washing correctly, it will then be removed after bypass surgery, the patient comes out with impella support.No harm to the patient linked to the balloon.The first balloon has been tested by placing it in a basin and testing the patency of the line, was possible to flush but it was not possible to aspire.
Event or Problem Description
It was reported that balloon is inserted under angiographic guidance, already during insertion of the 0.018 guide inside the baloon the customer feels more difficulty than usual, once the guide has been removed the customer is preparing to aspirate and wash the balloon, but nothing came from the washing line, aspiration with a 50cc syringe is difficult and infusion practically impossible.In agreement with the doctor, it is decided to go back up with the guide, with difficulty they manage to go up again, but in any case no patency in aspiration after the guide has been removed.So it is decided to change the balloon, where the guide climbs well, the insertion and positioning always under the guide occurs without problems, but a bit of difficulty in aspirating and infusing is still recorded, but it is decided to continue the therapy.No harm.

• Brand Name: SENSATION 7FR. 40CC 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: 23669465
• Report Number: 2248146-2025-0000785
• Device Sequence Number: 9846609
• Product Code: DSP
• UDI-Device Identifier: 10607567106779
• UDI-Public: (01)10607567106779(10)3000475243(17)280515(11)250515
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K063525
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/30/2026

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: 0684-00-0470-01
• Device Catalogue Number: 0684-00-0470-01
• Device Lot Number: 3000475243
• 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: 11/04/2025
• Supplement Date Received by Manufacturer: 01/22/2026; 01/30/2026
• Initial Report FDA Received Date: 11/28/2025
• Supplement Report FDA Received Date: 01/22/2026; 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/15/2025
• 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: IMPELLA.
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 80 KG