MAUDE Adverse Event Report: DATASCOPE CORP. LINEAR 7.5FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0480-01
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to character restrictions in block e.1.: full initial reporter name is: (b)(6).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).
Event or Problem Description
It was reported that during intra aortic balloon (iab) therapy it was unable to obtain an ap on a cardiosave from the inner lumen of a linear 40cc iab.The inner lumen is clotted off and they are unable to aspirate any blood back.There was no patient harm or injury reported.
Additional Manufacturer Narrative
Updated fields - b4, d9, g3, g6, h2, h3, h6 ( type of investigation, investigation findings, investigation conclusion), h11.No decon or visual inspection performed since product was not returned and could not be evaluated.A customer from a cardiac cath lab reported an issue via the emergency support line involving difficulty obtaining an arterial pressure (ap) signal on a cardiosave iabp (intra-aortic balloon pump) using a linear 40cc iab.Initially, the inner lumen of the iab appeared clotted, preventing blood aspiration.The customer was advised on alternate ap sources and confirmed no patient harm or therapy interruption.Later, the iab was replaced, but the ap signal issue persisted despite the new iab having a patent lumen.Troubleshooting attempts were unsuccessful due to environmental distractions.Switching to a different cardiosave unit resolved the issue, and therapy continued without incident.The faulty cardiosave¿s serial number was recorded for service.No patient information was shared, and relevant personnel were notified.The likely root cause is a malfunction in the original cardiosave unit¿s ap acquisition system, not the iab itself.This is supported by: the issue persisted across two separate iabs.The second iab had a confirmed patent lumen.Switching to a different cardiosave resolved the issue immediately.This points to a device-specific failure - possibly in the pressure transducer, internal signal processing, or connector interface of the original cardiosave unit.Reference complaint - (b)(4).
Event or Problem Description
N/a.

• Brand Name: LINEAR 7.5FR. 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: 23364801
• Report Number: 2248146-2025-0000647
• Device Sequence Number: 8916114
• Product Code: DSP
• UDI-Device Identifier: 10607567106564
• UDI-Public: (01)10607567106564(10)3000293882(17)260129(11)230130
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K041281
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2025

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 Expiration Date: 01/29/2026
• Device Model Number: 0684-00-0480-01
• Device Catalogue Number: 0684-00-0480-01
• Device Lot Number: 3000293882
• 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: 10/03/2025
• Supplement Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/30/2023
• 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