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	Leak/Splash (1354); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h11.Corrected fields: d4 (lot #, udi number), h6 (medical device ¿ problem code).
Additional Manufacturer Narrative
Other contact person phone number: (b)(6).User called into emergency support program line to request support with a cardiosave intra-aortic balloon pump(iabp) gas loss alarm.(b)(6), a cardio fellow, stated the nurses had change out the pump; however, the 2nd pump continued to alarm gas loss also.When asked, (b)(6) stated they were disconnecting the helium tubing to resolve the gas loss alarm.She and esp personnel performed proper troubleshooting: verify the helium tubing had no blood or discoloration.Press the iab fill key for 2-3 seconds, press start, and check the helium tubing again.The pump resumed without issue.While esp personnel and (b)(6) were discussing the nature of this alarm and different clinical possibilities, the pump alarmed gas loss again.Esp personnel and (b)(6) check for blood or discoloration in the helium tubing, turn down the augmentation by 2 levels to 8 out of 10 bars, press the iab fill key for 2-3 seconds, press start, and check the helium tubing again.The pump again started without issue.There was no obvious clinical explanation for the alarm at that time.Esp personnel explained if the pump continued to alarm gas loss then there was most likely an issue with the balloon.Esp personnel advised to go ahead and speak with the attending physician about issue.There was no patient harm or injury reported.
Event or Problem Description
User called into emergency support program line to request support with an intra-aortic balloon(iab) gas loss alarm.(b)(6), a cardio fellow, stated the nurses had change out the pump; however, the 2nd pump continued to alarm gas loss also.When asked, (b)(6) stated they were disconnecting the helium tubing to resolve the gas loss alarm.She and esp personnel performed proper troubleshooting: verify the helium tubing had no blood or discoloration.Press the iab fill key for 2-3 seconds, press start and check the helium tubing again.The pump resumed without issue.While esp personnel and (b)(6) were discussing the nature of this alarm and different clinical possibilities, the pump alarmed gas loss again.Esp personnel and (b)(6) check for blood or discoloration in the helium tubing, turn down the augmentation by 2 levels to 8 out of 10 bars, press the iab fill key for 2-3 seconds, press start, and check the helium tubing again.The pump again started without issue.There was no obvious clinical explanation for the alarm at that time.Esp personnel explained if the pump continued to alarm gas loss, then there was most likely an issue with the balloon.Esp personnel advised to go ahead and speak with the attending physician about issue.There was no patient harm or injury reported.

• 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: 24001692
• Report Number: 2248146-2026-0000140
• Device Sequence Number: 10398360
• Product Code: DSP
• UDI-Device Identifier: 10607567106564
• UDI-Public: (01)10607567106564(10)3000425185(17)271014(11)241014
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2026

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: 0684-00-0480-01
• Device Catalogue Number: 0684-00-0480-01
• Device Lot Number: 3000425185
• 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: 12/16/2025
• Supplement Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 01/08/2026
• Supplement Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/14/2024
• 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: 2 CARDIOSAVE PUMPS; CARDIOSAVE
• Patient Age: 67 YR
• Patient Sex: Male