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	Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a problem with baloon catheter linear 40cc.A kink was observed at the junction of the iab catheter, preventing guidewire passage despite multiple attempts.A new balloon was inserted into the patient.No harm was reported.
Additional Manufacturer Narrative
Other contact phone number: (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).

• 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: 24785044
• Report Number: 2248146-2026-0000851
• Device Sequence Number: 13243133
• Product Code: DSP
• UDI-Device Identifier: 10607567109718
• UDI-Public: (01)10607567109718(10)3000449608(17)280129(11)250129
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/15/2026

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
• Device Lot Number: 3000449608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2026
• Supplement Date Received by Manufacturer: 05/13/2026; 05/15/2026
• Initial Report FDA Received Date: 04/04/2026
• Supplement Report FDA Received Date: 05/15/2026; 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 77 KG