MAUDE Adverse Event Report: DATASCOPE CORP. SENSATION PLUS 8FR 50CC IAB WITH ACCESSORIES (W/PRESSURE TUBES, NO STYLET, W/O S; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0576-05
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to character limitation d1.Brand name: sensation plus 8fr 50cc iab with accessories (w/pressure tubes, no stylet, w/o statlock) (china).Due to character limitation in e1.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 during use after inserting the sensation plus 8fr 50cc intra aortic balloon(iab) catheter an arterial line waveform.Arterial pressure was reading 283/281.Prior to the call, the arterial pressure was 70/50.The inner lumen was clotted so it needed to be capped, and the transducer tubing connected to the inner lumen needed to be disconnected and discarded.It was stated the patient had a radial arterial site.No patient harm or injury reported.
Additional Manufacturer Narrative
Updated data: b4, g3, g6, h1, h2.Corrected data: g2 (report source).
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated data: b4, g3, g6, h1, h2.Corrected data: h6 (type of investigation).
Additional Manufacturer Narrative
Updated fields: b4, d9, g3, g6, h2, h3, h6(type of investigation, investigation findings, investigation conclusions), h11.Corrected fields: d1, d7a.No decon or visual inspection performed since product was not returned and could not be evaluated.Deidra, a cvicu nurse, reported abnormal arterial line readings and was unable to aspirate the inner lumen.The esp representative identified the lumen as likely clotted and advised capping it, discarding the transducer tubing, and labeling it ¿do not use.¿ an alternate pressure source was recommended for accurate pump timing.Deidra then successfully transduced the radial arterial site with guidance.The issue stemmed from continued use of a clotted lumen, leading to inaccurate readings and thrombus risk.Based on the event description, the root cause has been identified as user error.There was no malfunction of the iab; rather, the customer required assistance to navigate the proper use of the device.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.Complaint reference no.(b)(4).
Event or Problem Description
N/a.

• Brand Name: SENSATION PLUS 8FR 50CC IAB WITH ACCESSORIES (W/PRESSURE TUBES, NO STYLET, W/O S
• 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: 22641165
• Report Number: 2248146-2025-0000427
• Device Sequence Number: 20150352
• Product Code: DSP
• UDI-Device Identifier: 10607567109381
• UDI-Public: (01)10607567109381(10)3000472788(17)280502(11)250502
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K133074
• 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,Followup,Followup
• Report Date (Section B): 10/01/2025

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: 0684-00-0576-05
• Device Catalogue Number: 0684-00-0576-05
• Device Lot Number: 3000472788
• 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: 07/14/2025
• Supplement Date Received by Manufacturer: 09/23/2025; 09/30/2025; 10/01/2025
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 09/24/2025; 09/30/2025; 10/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/02/2025
• 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: UNKNOWN.
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 60 KG