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	Restricted Flow rate (1248); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use of balloon catheter intra-aortic balloon (iab) had catheter restriction alarm on the cardiosave.There was no patient harm reported.
Additional Manufacturer Narrative
Due to character limitation, below field are added from e1- initial reporter : (b)(6).Event site name : (b)(6).A supplemental report will be submitted upon completion of our investigation.
Additional Manufacturer Narrative
Updated: b4, d9, g3, g6, h6 (type of investigation, investigation findings, investigation conclusions, component codes), h11.Corrected fields: d4, d10, h6 (medical device problem code).A customer reported that the alarm occurred after the patient bent their leg.Troubleshooting was conducted with the medical team, confirming that the device was functioning correctly and there was no patient harm.The issue was identified as user-related due to the patient¿s leg position affecting catheter function.The bedside nurse followed the instructions for use (ifu) to successfully restart therapy.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated data: b4, g3, g6, h1, h2, h11.Corrected data: h6 (type of investigation, investigation findings).

• 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: 23287481
• Report Number: 2248146-2025-0000616
• Device Sequence Number: 12975414
• Product Code: DSP
• UDI-Device Identifier: 10607567106779
• UDI-Public: (01)10607567106779(10)3000421044(17)270930(11)240930
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K063525
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/17/2025

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: 0684-00-0470-01
• Device Catalogue Number: 0684-00-0470-01
• Device Lot Number: 3000421044
• 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: 09/25/2025
• Supplement Date Received by Manufacturer: 11/04/2025; 11/17/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/17/2025; 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/30/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARDIOSAVE IABP.; UNKNOWN.
• Patient Sex: Unknown