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	Inability to Auto-Fill (1044); Leak/Splash (1354); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to character restrictions in block e1 initial reporting: (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 id: (b)(4).
Event or Problem Description
It was reported that intra-aortic balloon(iab) while putting iab through femoral route after entering 5-7cm blood started collecting in the balloon.No harm reported.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h11.Corrected fields: b7.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields - b4, d9 device available for evaluation and date return to manufacturer, g3, g6, h2, h3, h6 (type of investigation, investigation findings, component code, investigation conclusions), h11.Corrected field: b5, d4 (version/model#), serial # should have left blank in previous mdr report, h6 medical device problem code.(b)(6) reported patient with axillary iab alarming multiple leak in iab circuit and autofill failures.No blood in tubing was reported and catheter was repositioned due to retractions sometimes 1-2 times per day.Catheter was replaced and is available for evaluation.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 into two separate pieces.The maquet 7.5fr sheath was returned covering the catheter tubing.One kink was observed on the catheter tubing 76.7cm from the iab tip.The extender tubing, pressure tubing and three way-stopcock were returned.An underwater leak test of the balloon membrane, catheter tubing, extracoporeal tubing, extender tubing and pressure tubing 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 alarms.The evaluation was unable to confirm the reported failures due to the returned condition of the iab.It was difficult to preform a pumping 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.A lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.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.The evaluation was unable to confirm the reported failures due to the returned condition of the iab.It was difficult to perform a pumping 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.A lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.
Event or Problem Description
It was reported that patient with axillary iab alarming multiple leak in iab circuit and autofill failures.No blood in tubing was reported and catheter was repositioned due to retractions sometimes 1-2 times per day.No harm.

• 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: 23288155
• Report Number: 2248146-2025-0000614
• Device Sequence Number: 8854690
• Product Code: DSP
• UDI-Device Identifier: 10607567106564
• UDI-Public: (01)10607567106564(10)3000432540(17)271119(11)241119
• 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 Practitioner
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/20/2025

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
• Device Lot Number: 3000432540
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2025
• Supplement Date Received by Manufacturer: 11/13/2025; 11/20/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/14/2025; 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2024
• 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: CS300.
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Weight: 84 KG