MAUDE Adverse Event Report: DATASCOPE CORP. LINEAR 7.5FR. 40CC IAB (WITH APA); SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0480-02
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: due to characterization limit e1 (event site name: (b)(6).Initial reporter: (b)(6)).A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that during use intra-aortic balloon (iab) catheter failed during the procedure.There was no harm to the patient.
Additional Manufacturer Narrative
Updated fields - a2, a3, a4, b4, d4 (expiry date), d9, g3, g6, h2, h3, h4, h6 (type of investigation, investigation findings, investigation conclusions), h11.Correction fields: d1, d4 (catalog#, version #, udi).Additional information: contact person name: doctor br, natalia, occupation: physician the customer reported that during the procedure, the iabp catheter malfunctioned.The client confirmed that the patient was not harmed.The malfunction of the device was not specified by the customer.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.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).
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h11.Corrected fields: d1 (brand name).

• Brand Name: LINEAR 7.5FR. 40CC IAB (WITH APA)
• 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: 23345206
• Report Number: 2248146-2025-0000634
• Device Sequence Number: 9461580
• Product Code: DSP
• UDI-Device Identifier: 10607567106571
• UDI-Public: (01)10607567106571(10)3000345019(17)261031(11)231031
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K041281
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/12/2025

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: 0684-00-0480-02
• Device Catalogue Number: 0684-00-0480-02
• Device Lot Number: 3000345019
• 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: 09/30/2025
• Supplement Date Received by Manufacturer: 12/03/2025; 12/12/2025
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 12/09/2025; 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/31/2023
• 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: CARDIOSAVE.
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 90 KG