MAUDE Adverse Event Report: CENTERPOINT SYSTEMS DELIVERY CATHETER SSPC3; LEAD CATHETER ACCESSORY

Model Number	9183
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this accessory guiding catheter exhibited a curve formation failure which might be due to heat related anomaly or repeated repositioning which the lead could no longer be directed tangent toward the septum and appeared unable to reach the site where placement was initially attempted.This accessory was out of service.No adverse patient effects were reported.
Additional Manufacturer Narrative
The lead catheter was not returned for analysis; therefore, a technical analysis could not be performed.The lead catheter was discarded and will not be returned for analysis.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of unable to exclude device problem.
Event or Problem Description
It was reported that this accessory guiding catheter exhibited a curve formation failure which might be due to heat related anomaly or repeated repositioning which the lead could no longer be directed tangent toward the septum and appeared unable to reach the site where placement was initially attempted.This accessory was out of service.No 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: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 24410961
• Report Number: 2124215-2026-09740
• Device Sequence Number: 13406095
• Product Code: DQY
• UDI-Device Identifier: 00810024671830
• UDI-Public: (01)00810024671830
• 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,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2026

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: 10/01/2026
• Device Model Number: 9183
• Device Catalogue Number: 9183
• Device Lot Number: CL13184
• 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: 01/30/2026
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 02/22/2026
• Supplement Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2024
• 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