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 Codes	Restricted Flow rate (1248); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon catheter intra-aortic balloon (iab) had alarm of ab catheter restriction.The rn observed blood in the tubing and immediately placed the pump in standby mode and clamped the tubing.No blood entered the pump.The catheter was subsequently removed and replaced with a new one.There was no harm reported.
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
Additional Manufacturer Narrative
Updated fields - b4, d9 device available for evaluation and date return to manufacture, g3, g6, h2, h3, h6 (type of investigation, investigation findings, component code, investigation conclusions), h11.Correctional field: e3.(b)(6) reached out regarding a patient with an axillary iab catheter that triggered a 'catheter restriction' alarm on day 16 of initial therapy.She mentioned calling the esp line and speaking with a representative who requested additional information.The bedside nurse observed blood in the tubing, placed the pump in standby mode, and clamped the tubing.No blood entered the cardiosave pump.The catheter was subsequently removed and replaced with a new one.The original catheter is available for evaluation, but it was cut at the y-fitting, which was discarded, and no serial number is available.The product was returned with the membrane completely unfolded and blood on the interior and exterior of the iab and between catheter and sheath.The iab was returned cut with only the membrane and a partial piece of the catheter tubing included.The maquet sheath was returned covering the catheter tubing.One kink was observed on the catheter tubing 51.6cm from the iab tip.An underwater leak test of the balloon membrane and the portion of catheter tubing returned was performed and no leaks were found.Due to the condition of the returned iab, it could not be connected to the pump to attempt replicating the reported alarm.The evaluation was unable to confirm the reported failure.It was difficult to preform additional leak tests and pump test due to the condition of the returned iab.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.The failure mode is addressed in the risk file and is operating within its risk profile.The ifu addresses 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.Each iab manufactured is 100% inspected and the controls put in place during the manufacturing of the iab would catch a defect and not allow non-conforming device to be released.The trend review did not identify an adverse trend (increase in number of complaints over past three (3) months).

• 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: 23277312
• Report Number: 2248146-2025-0000610
• Device Sequence Number: 21034963
• Product Code: DSP
• UDI-Device Identifier: 10607567106564
• UDI-Public: (01)10607567106564
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2025

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: 0684-00-0480-01
• Device Catalogue Number: 0684-00-0480-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2025
• Supplement Date Received by Manufacturer: 11/10/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 69 YR
• Patient Sex: Male
• Patient Weight: 85 KG