MAUDE Adverse Event Report: DATASCOPE CORP. SENSATION 7FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0470-01
Medical Device Problem Code	Moisture or Humidity Problem (2986)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to character restrictions in block e1 the two initial reporters name are (b)(6).Udi number is incomplete because the fields mfg date, exp date, lot number serial number is not available.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 record id (b)(4).
Event or Problem Description
It was reported that during intra aortic balloon (iab) therapy the customer inquired about condensation in the helium tubing, the condensation was clear and there were no signs of blood or discoloration.There was no patient harm or injury reported.
Additional Manufacturer Narrative
Updated fields: b4; d9; d4 udi number; g3; g6; h2; h3; h6 type of investigation, investigation findings, investigation conclusion; h11 corrected fields: g1 contact person ¿ mfg site; g2 udi # is incomplete as the catalog#, lot #, manufacture date, exp.Date were not provided.This information was requested from the customer; however, despite our best efforts, no information has been received.If any pertinent information is received in the future, a supplemental report will be submitted.No decon or visual inspection performed since product was not returned and could not be evaluated.Therefore, we were unable to confirm or determine a root cause for the reported failure.The failure mode is addressed in the risk file and is operating within its risk profile.The ifu addresses 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.Each iab manufactured is 100% inspected and the controls put in place during the manufacturing of the iab would catch a defect and not allow non-conforming device to be released.The trend review did not identify an adverse trend (increase in number of complaints over past three (3) months).
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields - b4, g3, g6, h2, h6 (investigation findings), h11.Corrected field: h6 investigation findings.No decon or visual inspection performed since product was not returned and could not be evaluated.An icu nurse called about condensation observed in helium tubing during patient use.A video was sent to the esp caller of the condensation and a dependent loop was found with a small amount of clear condensation in the lowest part of the tubing.Troubleshooting steps were preformed by the guidance for the esp caller for the nurse to disconnect the helium tubing to drain the condensation and resume pumping and the issue was resolved by repositioning the tubing to eliminate the loop and drain the condensation.Based on the event description, the root cause has been identified to be due to improper tubing positioning, specifically the presence of dependent loop in the helium tubing allowed condensation to accumulate at the lowest point.This configuration prevented the pump from effectively clearing the condensation during operation.There was no malfunction of the iab; rather, the customer required assistance to navigate the proper use of the device.The navigation provided was not in response to an issue or failure, but solely to guide the healthcare provider in operating the iab correctly.The failure mode is addressed in the risk file and is operating within its risk profile.The ifu addresses 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.Each iab manufactured is 100% inspected and the controls put in place during the manufacturing of the iab would catch a defect and not allow non-conforming device to be released.The trend review did not identify an adverse trend (increase in number of complaints over past three (3) months).

• Brand Name: SENSATION 7FR. 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: 22491718
• Report Number: 2248146-2025-0000371
• Device Sequence Number: 7940731
• Product Code: DSP
• UDI-Device Identifier: 10607567106779
• UDI-Public: (01)10607567106779
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K063525
• 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
• Report Date (Section B): 09/29/2025

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: 0684-00-0470-01
• Device Catalogue Number: 0684-00-0470-01
• 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: 06/28/2025
• Supplement Date Received by Manufacturer: 08/11/2025; 09/29/2025
• Initial Report FDA Received Date: 07/14/2025
• Supplement Report FDA Received Date: 08/19/2025; 09/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: PUMP
• Patient Sex: Unknown