MAUDE Adverse Event Report: CENTERPOINT SYSTEMS DELIVERY CATHETER SSPC2; CATHETER, PERCUTANEOUS

Model Number	9182
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this catheter was severely bent in the middle part resulting in placement difficulty.A new lead and catheter were used to proceed with the implant.This catheter was discarded due to contamination and will not be returned.No adverse patient effects were reported.

• Brand Name: DELIVERY CATHETER SSPC2
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): CENTERPOINT SYSTEMS; 3338 parkway blvd west; valley city UT 84119
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 24144459
• Report Number: 2124215-2026-03985
• Device Sequence Number: 15786573
• Product Code: DQY
• UDI-Device Identifier: 00810024671823
• UDI-Public: (01)00810024671823
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/22/2026

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: 9182
• Device Catalogue Number: 9182
• 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: 12/29/2025
• Initial Report FDA Received Date: 01/22/2026
• 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
• Patient Age: 71 YR
• Patient Sex: Male