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	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Updated fields - b4, g3, g6, h2, h6 (health effect ¿ clinical code), h11.Corrected field - d4(expiration date, udi), d10, h4(device manufacture date), h6(component codes).
Event or Problem Description
(b)(6), an rn in the cvicu, called into emergency support program line to request support with a clotted inner lumen.Esp personnel reviewed a screenshot that showed 244/243 as the arterial pressure.Esp personnel explained that since the inner lumen was clotted, it needed to be capped, and the transducer tubing connected to the inner lumen needed to be disconnected and discarded.Esp personnel also explained the inner lumen needed to be labeled do not use due to risk for thrombus.Esp personnel explained to (b)(6) that the radial arterial line would need to be transduced to the pump as the alternate pressure source to safely and appropriately time the pump.(b)(6) stated that he would call directly if he was unable to transduce the radial arterial line to the pump.There was no patient harm or injury reported.
Additional Manufacturer Narrative
Other contact phone number: (b)(6).(b)(6), an rn in the cvicu, called into emergency support program line to request support with a clotted inner lumen.Esp personnel reviewed a screenshot that showed 244/243 as the arterial pressure.Esp personnel explained that since the inner lumen was clotted, it needed to be capped, and the transducer tubing connected to the inner lumen needed to be disconnected and discarded.Esp personnel also explained the inner lumen needed to be labeled do not use due to risk for thrombus.Esp personnel explained to (b)(6) that the radial arterial line would need to be transduced to the pump as the alternate pressure source to safely and appropriately time the pump.(b)(6) stated that he would call directly if he was unable to transduce the radial arterial line to the pump.There was no patient harm or injury reported.

• 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: 24035040
• Report Number: 2248146-2026-0000206
• Device Sequence Number: 15738258
• Product Code: DSP
• UDI-Device Identifier: 10607567106571
• UDI-Public: (01)10607567106571(10)3000440308(17)280107(11)240107
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K041281
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2026

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: 3000440308
• 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: 12/21/2025
• Supplement Date Received by Manufacturer: 02/07/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 02/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/07/2024
• 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: 56 YR
• Patient Sex: Male
• Patient Weight: 93 KG