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 Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported during use that the intra-aortic balloon (iab) catheter had blood present in the tubing, which did not enter the cs300 pump.The catheter was discontinued and replaced with a second linear 40cc catheter.There was no harm reported.
Additional Manufacturer Narrative
Updated fields - b4, d9 date return to manufacture and device available for evaluation, g3, g6, h2, h3, h6 (type of investigation, investigation findings, component code, investigation conclusions), h11.A portion of the catheter tubing was returned along with the extender tubing.The membrane and portion of the catheter tubing was cut from the iab and not returned.A visual examination of the product detected the inner lumen within the catheter tubing was completely separated within a kink approximately 0.3cm from y-fitting.The inner lumen was found occluded with dried blood.The occlusion was unable to be cleared.An underwater leak test of the portion of catheter tubing, y-fitting, extracorporeal and extender tubing was performed and no other leaks were detected.The evaluation determined an inner lumen break within a catheter kink causing the reported problem.It is difficult to determine when or how this occurred.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 iab failure.The evaluation confirmed the reported problem.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.
Event or Problem Description
N/a.

• 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: 23277373
• Report Number: 2248146-2025-0000611
• Device Sequence Number: 8762146
• Product Code: DSP
• UDI-Device Identifier: 10607567106564
• UDI-Public: (01)10607567106564(10)3000293882(17)260129(11)230130
• 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
• 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 Expiration Date: 01/29/2026
• Device Model Number: 0684-00-0480-01
• Device Catalogue Number: 0684-00-0480-01
• Device Lot Number: 3000293882
• 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: 11/10/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2023
• 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: 81 KG