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

Model Number	0684-00-0470-01U
Medical Device Problem Codes	Fluid/Blood Leak (1250); Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the intra aortic balloon (iab) therapy the catheter was placed through an axillary approach, off lable.When trying to get the patient in a standing position from sitting the iabp began to alarm "check iabp catheter" and blood was noticed in the helium tubing.The catheter was removed with no harm to the patient.
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
Additional Manufacturer Narrative
Updated fields: b4, d9, e1 (initial reporter, event site email), g1 (contact person ¿ mfg site), g2, g3, g6, h2, h3, h6 (medical device ¿ problem code, type of investigation, investigation conclusions), h11.Corrected fields: d4 (lot no., udi no.), e2.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.Reference id: (b)(4).

• Brand Name: SENSATION 7FR. 40CC IAB WITH ACCESSORIES, US ONLY
• 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: henry pena ; 15 law drive; fairfield, NJ 07004
• MDR Report Key: 21077544
• Report Number: 2248146-2025-0000010
• Device Sequence Number: 8497903
• Product Code: DSP
• UDI-Device Identifier: 10607567109558
• UDI-Public: (01)10607567109558(10)3000372063(17)270304(11)240304
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2025

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: 0684-00-0470-01U
• Device Catalogue Number: 0684-00-0470-01U
• Device Lot Number: 3000372063
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2024
• Supplement Date Received by Manufacturer: 03/21/2025
• Initial Report FDA Received Date: 01/06/2025
• Supplement Report FDA Received Date: 03/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/04/2024
• 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: UNKNOWN IABP.
• Patient Sex: Unknown