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); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned and could not be evaluated.It was discarded by the user.We are unable to confirm the reported event.If new information becomes available, a supplemental report will be submitted.Complaint record id (b)(4).The additional reporter name is (b)(6).
Event or Problem Description
Esp- user called into emergency support program line stating they have just recently received a patient from an outlying facility.Patient is on iabp therapy with a cardiosave pump and sensation 7fr 40cc iab.They state they were changing out the pressure tubing that runs to the inner lumen of the iab per their hospital protocols upon receiving a patient.While doing this they discovered they could not flush or aspirate the inner lumen while in standby.The emergency service programme personel reviewed the inner lumen would have been the backup for the fo (which is operating as expected) and that the iab does not need to be replaced and instructed them that the iab does not need to be replaced and to treat the inner lumen as no longer patent per their hospital protocol.No harm or injury reported.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h6 (medical device problem code, type of investigation, investigation findings and investigation conclusions and component codes), h11 corrected fields: e3 and g2 the clinical staff were advised that the inner lumen of the iab serves as a backup for fiber optic (fo) pressure monitoring, which was confirmed to be functioning as expected.It was determined that replacement of the iab was not required.The clinicians were instructed to treat the inner lumen as non-patent and manage it per their hospital protocol.No further troubleshooting was requested, and the customer expressed appreciation for the guidance provided.
Event or Problem Description
N/a.

• 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: 23717382
• Report Number: 2248146-2025-0000811
• Device Sequence Number: 21397418
• Product Code: DSP
• UDI-Device Identifier: 10607567106779
• UDI-Public: (01)10607567106779
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2026

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2025
• Supplement Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Unknown