MAUDE Adverse Event Report: DATASCOPE CORP. LINEAR 7.5FR 25CC IAB WITH ACCESSORIES (APA) (TURKEY); SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0478-10
Medical Device Problem Codes	Increase in Pressure (1491); Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Updated fields: b4, d9, g3, g6, h2, h3, h4, h6 (medical device problem code, type of investigation, investigation findings, component codes and investigation conclusions), h11.No decon or visual inspection performed since product was not returned and could not be evaluated.(b)(6), an rn in the micu, contacted the emergency support line regarding a recurring gas gain alarm on a cardiosave iabp, with no reported patient harm.Initial troubleshooting steps, including using the start and iab fill keys and inspecting helium tubing, were performed, and the balloon was noted to be placed axillary.Despite switching to a second pump (os# (b)(4)), the alarm persisted, prompting further product surveillance and a recommendation to consider balloon exchange.The balloon, originally placed on (b)(6) 2025, was ultimately replaced in the cath lab due to continued alarms on both pumps based on the description, the recurring gas gain alarms were likely due to a compromised or malfunctioning intra-aortic balloon catheter, possibly exacerbated by the axillary placement, which is known to carry additional risks and limitations.It is impossible to define what could have caused the alarm since the product was not returned for investigation.The failure mode is addressed in the risk file and is operating within its risk profile.The ifu addresses the reported failure.There were no ncmrs identified which could cause or contribute to the reported failure.The investigation does not indicate that the device was inadvertently released as non-conforming or an adulterated product or was a counterfeit.The complaint history review did not identify an adverse trend (increase in number of complaints over past three (3) months).Based on the rational provided above, no escalation to the capa process is required.
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 record id # (b)(4).
Event or Problem Description
It was reported by customer, during use on patient cardiosave intra-aortic balloon pump (iabp) gas gain alarm that had occurred several times.No patient harm or injury reported.

• Brand Name: LINEAR 7.5FR 25CC IAB WITH ACCESSORIES (APA) (TURKEY)
• 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: 22869968
• Report Number: 2248146-2025-0000496
• Device Sequence Number: 15737461
• Product Code: DSP
• UDI-Device Identifier: 10607567113210
• UDI-Public: (01)10607567113210(10)3000393501(17)270530(11)240530
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K112372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2025

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: 0684-00-0478-10
• Device Catalogue Number: 0684-00-0478-10
• Device Lot Number: 3000393501
• 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: 08/04/2025
• Supplement Date Received by Manufacturer: 10/14/2025
• Initial Report FDA Received Date: 08/22/2025
• Supplement Report FDA Received Date: 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/30/2024
• 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: 58 YR
• Patient Sex: Female
• Patient Weight: 62 KG