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

Model Number	0684-00-0480-01U
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use intra-aortic balloon(iab) rn calls to report an incident that occurred 2 days ago.She reports a linear 40cc iab was seen with blood in the helium tubing.She states the blood did not get into the cs300 and was contained near the white ¿y¿ fitting.She states they dc¿d therapy and clamped the tubing for iab removal.The iab was an axillary placement that was indwelling the patient for 15 days.She states there is no harm to the patient due to this issue.
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.Complaint id: (b)(4).
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h3, h6(type of investigation, investigation findings, investigation conclusions), h11.The iab was returned cut in two parts with the membrane completely unfolded with blood on the interior and exterior of the catheter and between the catheter and the sheath.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.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal 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.Complaint id: (b)(4).

• Brand Name: LINEAR 7.5FR. 40CC IAB WITH ACCESSORIES, US ONLY
• 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: henry pena ; 15 law drive; fairfield, NJ 07004
• MDR Report Key: 21897493
• Report Number: 2248146-2025-0000245
• Device Sequence Number: 14311178
• Product Code: DSP
• UDI-Device Identifier: 10607567109527
• UDI-Public: (01)10607567109527(10)3000394237(17)270604(11)240604
• 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): 05/15/2025

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: 0684-00-0480-01U
• Device Catalogue Number: 0684-00-0480-01U
• Device Lot Number: 3000394237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2025
• Supplement Date Received by Manufacturer: 05/12/2025
• Initial Report FDA Received Date: 04/24/2025
• Supplement Report FDA Received Date: 05/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Sex: Female
• Patient Weight: 77 KG