MAUDE Adverse Event Report: DATASCOPE CORP. SENSATION PLUS 7.5FR. 40CC IAB W/ ACCESSORIES (W/O STATLOCK)(CHINA); SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0568-05
Medical Device Problem Codes	Inability to Auto-Fill (1044); Device Sensing Problem (2917); Gas/Air Leak (2946); Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to character limitation event site full name: (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 reference no.: (b)(4).
Event or Problem Description
It was reported that the after inserting the intra aortic balloon(iab) catheter had the fo sensor failure alarm and an autofill failure alarm on a cardiosave during use.No patient harm or injury was reported.
Additional Manufacturer Narrative
Updated data: b4, g3, g6, h1, h2.Corrected data: e1 (event site state).
Event or Problem Description
N/a.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: b4, d9, g3, g6, h2, h3, h6 (type of investigation, investigation findings, component codes and investigation conclusions), h11 corrected fields: g4 (pma/510k), h6 (medical device problem code).No decon or visual inspection performed since product was not returned and could not be evaluated.Megan, an rn in the hf icu, reported an autofill failure alarm on a cardiosave device during patient use.Initial troubleshooting revealed no kinks or blood in the helium extender tubing.Due to the ongoing pump exchange, further troubleshooting steps were declined.After switching to a new pump, a fiber-optic sensor failure alarm appeared.Attempts to resolve it by reconnecting the fo cable were unsuccessful, so the cable was labeled and removed from use.Transitioning to the transducer resolved all alarms, and therapy resumed without further issues.Based on the description, the customer experienced both an autofill failure on the original pump and a fiber-optic sensor failure on the new pump suggests a faulty or improperly fo cable connection, which persisted despite reconnection attempts.The inability to perform full troubleshooting before switching pumps limited the opportunity to isolate the exact cause.It is impossible to determine the root cause of both of the alarms since the iab was not yet returned to us for investigation.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).

• Brand Name: SENSATION PLUS 7.5FR. 40CC IAB W/ ACCESSORIES (W/O STATLOCK)(CHINA)
• 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: 22939567
• Report Number: 2248146-2025-0000515
• Device Sequence Number: 13227784
• Product Code: DSP
• UDI-Device Identifier: 10607567109442
• UDI-Public: (01)10607567109442(10)3000478158(17)280527(11)250527
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K122628
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/16/2025

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: 0684-00-0568-05
• Device Catalogue Number: 0684-00-0568-05
• Device Lot Number: 3000478158
• 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: 08/14/2025
• Supplement Date Received by Manufacturer: 10/15/2025; 10/16/2025
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 10/16/2025; 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/27/2025
• 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: IABP CARDIOSAVE.
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 74 KG