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

Model Number	0684-00-0480-07
Medical Device Problem Codes	Break (1069); Leak/Splash (1354); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during use that linear 40cc intra aortic balloon (iab) had balloon ruptured.There were no patient harm or injury was reported.
Additional Manufacturer Narrative
Due to character limit: e1 (event site name): (b)(6) hospital, e1 (initial reporter) dr.(b)(6).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 field: b4, d9, g3, g6, h2, h3, h6 (medical device ¿ problem code, type of investigation, investigation findings, investigation conclusions), h11.An intra-aortic balloon (iab) leak is the loss of integrity in the balloon membrane or its connections, allowing blood or gas to enter or escape.Causes: 1.User mishandling or not following ifu, 2.Membrane folding or resistance, 2.Patient-related factors (e.G., plaque abrasion), 3.Off-label use.
Event or Problem Description
N/a.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h11 corrected fields: h6 (type of investigation) keeping udi partial as product details are not provided.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h6 (type of investigation), h11.
Event or Problem Description
N/a.

• Brand Name: LINEAR 7.5FR. 40CC IAB (INDIA)
• 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: 24577221
• Report Number: 2248146-2026-0000759
• Device Sequence Number: 10474778
• Product Code: DSP
• UDI-Device Identifier: 10607567109718
• UDI-Public: (01)10607567109718
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/07/2026

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: 0684-00-0480-07
• Device Catalogue Number: 0684-00-0480-07
• 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: 02/18/2026
• Supplement Date Received by Manufacturer: 03/26/2026; 04/02/2026; 04/03/2026
• Initial Report FDA Received Date: 03/12/2026
• Supplement Report FDA Received Date: 03/31/2026; 04/02/2026; 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 59 YR
• Patient Sex: Male