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	Pacing Problem (1439); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Updated fields - b4, g3, g6, h2, h11.Corrected field - h6 (type of investigation, component code).
Event or Problem Description
It was reported by the customer via emergency support program line, that the intra aortic balloon (iab) linear 40cc had clotted inner lumen and difficult or unable to monitor arterial waveform.There were no patient harm or injury was reported.
Additional Manufacturer Narrative
The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.Complaint record id:(b)(4).
Additional Manufacturer Narrative
Updated fields: b4,d1,d4(catlog,model,udi),g2,g3,g6,h2,h6(type of investigation, investigation findings,component code, conclusion),h11.Nurse called for assistance with a clotted inner lumen of a linear catheter during use.The patient had arrived from the operating room the previous day and the arterial waveform on the pump was lost with inability to aspirate or flush.The nurse was advised to cap and label the inner lumen as clotted inner lumen do not use to prevent further use.She was also instructed to notify the provider at the bedside and to use an alternate arterial site such as the radial line for pressure monitoring.The nurse agreed with the plan and complaint information was obtained.The bedside team agreed to return the catheter after discontinuation and reported no further needs.
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: 24647280
• Report Number: 2248146-2026-0000800
• Device Sequence Number: 15913256
• 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: IL
• 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,Followup
• Report Date (Section B): 04/13/2026

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: 02/27/2026
• Supplement Date Received by Manufacturer: 03/30/2026; 04/13/2026
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 04/01/2026; 04/13/2026
• 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: IABP.
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 89 KG