MAUDE Adverse Event Report: DATASCOPE CORP. LINEAR 7.5FR. 34CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0479-01
Medical Device Problem Code	Restricted Flow rate (1248)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2025
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 record id # (b)(4).
Event or Problem Description
It was reported that customer called for an assistance during use of intra aortic balloon through a direct call to the emergency support program personel.The customer verified there was no blood in the helium tubing and that all connections were appropriate and secure.Esp team member instructed customer to press the iab fill key and restart which resolved the alarm.Troubleshooting determined an off-brand sheath with an arterial pigtail was in use.The esp team member informed her of getinge¿s recommendations for using the sheath provided with the balloon kit related to the wire reinforced sheath that helps prevent kinks in the balloon catheter.No patient harm or injury was reported.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: b4, d9, g3, g6, h2, h3, h6 (type of investigation, investigation findings, investigation conclusions), h11 no decon or visual inspection performed since product was not returned and could not be evaluated.A customer contacted the emergency support program regarding a catheter restriction alarm on a cardiosave iabp during use.The icu nurse, (b)(6), confirmed no patient harm occurred.Initial troubleshooting verified that the linear balloon catheter and pump were functioning correctly.The alarm was resolved by performing a manual iab fill and restarting therapy.Further investigation revealed that an off-brand sheath with an arterial pigtail was being used, which may have contributed to the restriction.The nurse was advised to use the getinge-recommended wire-reinforced sheath to prevent kinking.Nursing interventions were reviewed, and the nurse was encouraged to reach out again if needed.Based on the event description, use of an off-brand sheath with an arterial pigtail, which is not recommended by the manufacturer, may cause a restriction in the balloon catheter leading to the alarm.However since the product was not returned, we were unable to evaluate the device.Therefore, the reported failure cannot be confirmed and cannot determine a root cause.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.Based on the event description, use of an off-brand sheath with an arterial pigtail, which is not recommended by the manufacturer, may cause a restriction in the balloon catheter leading to the alarm.However since the product was not returned, we were unable to evaluate the device.Therefore, the reported failure cannot be confirmed and cannot determine a root cause.
Additional Manufacturer Narrative
Updated data: b4, g3, g6, h1, h2.Corrected data: d4 lot.

• Brand Name: LINEAR 7.5FR. 34CC 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.; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer Contact: ewelina chorlowska ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 23461762
• Report Number: 2248146-2025-0000686
• Device Sequence Number: 15724652
• Product Code: DSP
• UDI-Device Identifier: 10607567106557
• UDI-Public: (01)10607567106557(10)3000454987
• Combination Product (Y/N): N
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/24/2025

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: 0684-00-0479-01
• Device Catalogue Number: 0684-00-0479-01
• Device Lot Number: 3000454987
• 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: 10/10/2025
• Supplement Date Received by Manufacturer: 11/17/2025; 11/24/2025
• Initial Report FDA Received Date: 11/04/2025
• Supplement Report FDA Received Date: 11/24/2025; 11/24/2025
• 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 PUMP AND OFF-BRAND SHEATH
• Patient Sex: Female