MAUDE Adverse Event Report: CenterPoint Systems Delivery Catheter SSPC3; Lead Catheter Accessory

Model Number	9183
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	09/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this accessory guidewire exhibited perforation during procedure.Which possibly caused by the guiding being directed toward the hinge side.This accessory was out of service.No additional adverse patient effects were reported.

• Brand Name: Delivery Catheter SSPC3
• Common Device Name: Lead Catheter Accessory
• 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: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50945912
• Report Number: 2124215-2026-51938
• Device Sequence Number: 9534634
• Product Code: DQY
• UDI-Device Identifier: 00810024671830
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9183
• Device Catalogue Number: 9183
• Device Lot Number: CL15872
• 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: 09/17/2026
• Initial Report FDA Received Date: 09/30/2026
• Date Device Manufactured: 05/19/2026
• 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
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization; Required Intervention
• Patient Sex: Unknown