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	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Updated data: b4, g3, g6, h1, h2, h11.Corrected data: corrected field:e1 (event site city, state code)event site address line 2: will be blank.
Event or Problem Description
N/a.
Event or Problem Description
It was reported through a direct call from the customer, stating that the patient was stable but augmentation was lower than the systolic.It was also mentioned that the inner lumen of intra-aortic balloon (iab) was clotted.It was determined that the alleged issue was not related to a device malfunction, rather user error that allowed the inner lumen to clot.No patient harm or injury reported.
Additional Manufacturer Narrative
Additional information: due to characterization limit e.1.Event site name: (b)(6).A supplemental report will be submitted upon completion of our investigation.Complaint id# (b)(4).
Additional Manufacturer Narrative
Updated fields: b4, d9(device available for eval), g3, g6, h2, h3, h6(type of investigation, investigation findings, component codes, 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 regarding low augmentation on a cardiosave iabp.Troubleshooting with the fellow and (b)(6) confirmed the catheter and pump were functioning as intended, with no patient harm reported.The issue was traced to a clotted inner lumen, likely due to user error (inadequate or missed flushing).The inner lumen could not be aspirated, and guidance was provided to cap it and use an alternate arterial pressure source.It was also clarified in the call that it is not recommended systemic heparin or continued use of a clotted lumen.Miscommunication was identified between the overnight resident and esp regarding the use of the clotted lumen.User error ¿ failure to maintain inner lumen patency, leading to clot formation.This resulted in inaccurate pressure readings and low augmentation.Additionally, there was miscommunication regarding appropriate response to a clotted lumen, contributing to improper continuation of therapy.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 id# (b)(4).

• 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: 23307075
• Report Number: 2248146-2025-0000626
• Device Sequence Number: 20287405
• Product Code: DSP
• UDI-Device Identifier: 10607567106779
• UDI-Public: (01)10607567106779(10)3000421044(17)270930(11)240930
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/17/2025

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
• Device Lot Number: 3000421044
• 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: 09/26/2025
• Supplement Date Received by Manufacturer: 10/30/2025; 11/17/2025
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 11/06/2025; 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/30/2024
• 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: PUMP
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 76 KG