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

Model Number	0684-00-0480-02
Medical Device Problem Codes	Inability to Auto-Fill (1044); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer via the emergency support program line that a cardiosave system intermittently alarmed with an autofill failure alarm during use with an intra aortic balloon (iab) linear 40 cc.No patient harm or injury was reported.
Additional Manufacturer Narrative
Due to character limit: e1.Event site name: (b)(6).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).
Additional Manufacturer Narrative
Updated fields - b4, d9, g3, g6, h2, h3, h4, 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 reporting intermittent autofill failure alarms on a cardiosave pump during use.No patient harm or injury occurred.Hardik, an md in the heart & lung transplant unit, explained that therapy could be restarted each time, but the alarms continued to recur.Troubleshooting confirmed the patient was stable with an axillary balloon, and an off label disclaimer was provided.During discussion, hardik noted the balloon catheter had a loop in its secured position but preferred not to adjust it overnight without a surgeon present.He also stated that three pumps had been exchanged prior to calling support.At the time of the call, the pump was no longer alarming.Hardik agreed to inspect the catheter for bends or kinks and planned to inform the day team to resecure the balloon to eliminate any tubing bends.Complaint information was collected, and hardik expressed appreciation with no further questions.Since the product was not returned, we were unable to perform a device evaluation.Based on the event description, the insertion was reported to be axillary, which is not the method described in the device instructions for use.This may have contributed to the reported failure.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.
Event or Problem Description
None.

• Brand Name: LINEAR 7.5FR. 40CC IAB (WITH APA)
• 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: 24244167
• Report Number: 2248146-2026-0000650
• Device Sequence Number: 21237060
• Product Code: DSP
• UDI-Device Identifier: 10607567106571
• UDI-Public: (01)10607567106571(10)3000440308(17)280107(11)240107
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2026

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: 0684-00-0480-02
• Device Catalogue Number: 0684-00-0480-02
• Device Lot Number: 3000440308
• 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: 01/11/2026
• Supplement Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/07/2024
• 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 (3 CONSOLES)
• Patient Age: 38 YR
• Patient Sex: Male