MAUDE Adverse Event Report: DATASCOPE CORP. SENSATION PLUS 7.5FR. 40CC IAB & ACCESSORIES; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0568-01
Medical Device Problem Codes	Appropriate Device Problem Term/Code Not Available (3191); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other contact phone number: (b)(6).The device was not returned and could not be evaluated.It was discarded by the user.We are unable to confirm the reported event.If new information becomes available, a supplemental report will be submitted.Complaint record id (b)(4).
Event or Problem Description
(b)(6), an icu rn, called into emergency support program line requesting assistance for an unable to update timing message.She reported she had troubleshot the message by flushing and aspirating the inner lumen and changing out the ecg electrodes, which did not resolve the message.She reported the patient was not on any other medical devices.A screenshot of the iabp monitor revealed an arterial line with mild artifact, and the unable to update timing message was no longer present.It also revealed a significant amount of ecg artifact.Esp personnel reviewed the nature of the message with (b)(6).A screenshot of the most recent chest xray (obtained at 3:00am on (b)(6) 2025) revealed the distal marker was in the 5th intercostal space.Esp personnel recommended consulting with the physician to discuss the placement of the balloon catheter and also recommended replacing the ecg electrodes, placing doppler gel on the back of each one, and placing the ecg electrodes as if they were ¿hugging the heart¿ to increase conduction.(b)(6) stated she would consider the recommendations, and did not need any additional troubleshooting assistance.No patient harm or injury reported.
Additional Manufacturer Narrative
Updated fields b4 d9 g3 g6 h2 h3 h6 type of investigation, investigation findings, investigation conclusions h11.No decon or visual inspection performed since product was not returned and could not be evaluated a complaint was received via a direct call to the emergency support program no patient harm was reported mary an icu rn sought assistance for an unable to update timing message on the iabp she had already flushed and aspirated the inner lumen and replaced the ecg electrodes but the issue persisted at that time she confirmed the patient was not connected to other medical devices a screenshot of the iabp monitor showed mild arterial line artifact and significant ecg artifact though the timing message had cleared review of the most recent chest x ray indicated that the distal marker was located in the 5th intercostal space outside recommended positioning recommendations were provided including consulting the physician about repositioning the balloon catheter replacing ecg electrodes with gel applied and positioning them to hug the heart for improved signal quality mary acknowledged the recommendations and required no further assistance since the product was not returned we were unable to perform a device evaluation based on the event description suboptimal iabp balloon catheter positioning distal marker in the 5th intercostal space likely caused intermittent failure of iab migration however the failure of update timing is a pump related failure and not related to the iab catheter failure.

• Brand Name: SENSATION PLUS 7.5FR. 40CC IAB & ACCESSORIES
• 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: 24206891
• Report Number: 2248146-2026-0000614
• Device Sequence Number: 14826567
• Product Code: DSP
• UDI-Device Identifier: 10607567108063
• UDI-Public: (01)10607567108063(10)3000319341(17)260614(11)230614
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2026

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 Expiration Date: 06/14/2026
• Device Model Number: 0684-00-0568-01
• Device Catalogue Number: 0684-00-0568-01
• Device Lot Number: 3000319341
• 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: 01/05/2026
• Supplement Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 01/29/2026
• Supplement Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/14/2023
• 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: CARDIOSAVE
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 63 KG