MAUDE Adverse Event Report: DATASCOPE CORP.; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0884-00-0019-23
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to character limit in block e1 telephone number: (b)(6) d1 brand name: insertion kit with 8fr.6¿ (15cm) introducer for use with the sensation plus 8fr 50cc iab a supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that intra-aortic balloon (iab) was unable to pass through shealth.No harm was reported.
Additional Manufacturer Narrative
Updated fields: b4, d9, g1 (contact person mfg site), g3, g6, h2, h3, h6 (type of investigation, investigation findings, component codes and investigation conclusions), h11.Due to character limit in block e1 (event site telephone): (b)(6).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.
Event or Problem Description
N/a.

• 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: lori gosselin ; 15 law drive; fairfield, NJ 07004
• MDR Report Key: 22147970
• Report Number: 2248146-2025-0000296
• Device Sequence Number: 12671012
• Product Code: DSP
• UDI-Device Identifier: 10607567108599
• UDI-Public: (01)10607567108599(10)3000440307(17)271220(11)241220
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K133074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2025

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: 0884-00-0019-23
• Device Catalogue Number: 0884-00-0019-23
• Device Lot Number: 3000440307
• 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: 05/21/2025
• Supplement Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 06/05/2025
• Supplement Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/20/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown