MAUDE Adverse Event Report: CENTERPOINT SYSTEMS; CATHETER, PERCUTANEOUS

Model Number	9287
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during insertion, when torque was applied to the guiding catheter (gc), force was exerted on the junction between the hub and the gc, causing the catheter to kink.A new catheter was used and the procedure was completed successfully.No adverse patient effects were reported.
Additional Manufacturer Narrative
This supplemental correction report was created to capture this event as non boston scientific product, thus this observation no longer meets the definition of complaint criteria.Amending mdr decision to mdr=no report.
Event or Problem Description
It was reported that during insertion, when torque was applied to the guiding catheter (gc), force was exerted on the junction between the hub and the gc, causing the catheter to kink.A new catheter was used and the procedure was completed successfully.No adverse patient effects were reported.

• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): CENTERPOINT SYSTEMS; 3338 parkway blvd west; valley city UT 84119
• Manufacturer (Section G): CENTERPOINT SYSTEMS; 3338 parkway blvd; west valley city UT 84119
• Manufacturer Contact: timothy degroot degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 24062896
• Report Number: 2124215-2026-02306
• Device Sequence Number: 16022741
• Product Code: DQY
• UDI-Device Identifier: 00810024670444
• UDI-Public: (01)00810024670444
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/23/2026

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 Expiration Date: 05/27/2026
• Device Model Number: 9287
• Device Catalogue Number: 9287
• Device Lot Number: CL14058
• 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: 12/17/2025
• Supplement Date Received by Manufacturer: 03/30/2026; 04/24/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 04/01/2026; 05/23/2026
• Date Device Manufactured: 05/27/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown