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 Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Vascular Problem (4441); Insufficient Information (4580)
Date of Event	06/10/2026
Type of Reportable Event	Death
Event or Problem Description
During a surgical procedure, a linear 40cc intra-aortic balloon (iab) catheter could not be advanced through the introducer due to an inability to pass the device.Due to the patient's hemodynamic condition, an alternative method of placement was performed.During subsequent device removal, a femoral vascular injury occurred, resulting in hemorrhage.Surgical intervention was required to repair the vessel and manage the bleeding.Patient deceased.According to the report, death is not attributed to the reported event at this stage.
Additional Manufacturer Narrative
Initial reporter: (b)(6).Event site name: (b)(6) event site address: (b)(6).Upon completion of the investigation into this event a follow up report will be submitted.
Additional Manufacturer Narrative
Updated fields: g3, g6, h2, h6 (health effect ¿ clinical code).Corrected fields: a3, d10.Upon completion of the investigation into this event a follow up report will be submitted.
Additional Manufacturer Narrative
Updated fields: b4, d4 (lot and udi), e2, e3, g3, g6, g7, h2, h6 (type of investigation, investigation findings and investigation conclusions), h11.Corrected field: d8 (revert this field to blank, as it was inadvertently submitted initially).It was reported that during a surgical procedure, a 40cc intra aortic balloon (iab) catheter could not be advanced through the introducer due to an inability to pass through the access site.Given the patient¿s critical hemodynamic status, an alternative placement approach was utilized.During subsequent device removal, a vascular injury occurred in the femoral region, resulting in hemorrhage that required surgical intervention.The patient had a pre existing critical condition with underlying ischemic heart disease and was later reported deceased; however, the death has not been attributed to the reported event.The device was reportedly disposed of and is not available for evaluation, although confirmation is pending regarding whether both the catheter and introducer were discarded.Since the product was not returned, we were unable to evaluate the device.Because the catheter and introducer were not returned for investigation, the exact cause of the reported issue could not be determined.Possible contributing factors include patient specific anatomical or vascular conditions, such as vessel tortuosity, calcification, stenosis, or peripheral vascular disease, which may have impeded catheter advancement through the introducer.The reported femoral vascular injury and subsequent hemorrhage may have occurred during insertion, manipulation, removal, or alternative placement attempts in the setting of fragile vasculature and the patient's compromised clinical condition.Additionally, procedural factors, access site challenges, or introducer device compatibility issues cannot be ruled out.Without the device for evaluation, a device related contribution could not be confirmed.No decon or visual inspection performed since product was not returned and could not be evaluated.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.
Event or Problem Description
N/a.

• 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: 25776360
• Report Number: 2248146-2026-0001256
• Device Sequence Number: 21218632
• Product Code: DSP
• UDI-Device Identifier: 10607567106571
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K041281
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 3000499388
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2026
• Supplement Date Received by Manufacturer: 08/21/2026; 09/08/2026
• Initial Report FDA Received Date: 07/10/2026
• Supplement Report FDA Received Date: 09/08/2026; 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/10/2025
• 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: Teleflex Arrow console.
• Outcome Attributed to Adverse Event: Death
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 176 LB