MAUDE Adverse Event Report: CENTERPOINT SYSTEMS DELIVERY CATHETER SSPC3

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	06/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this catheter was discontinued to use due to hemostasis valve broke and the back flow of blood could not be stopped.The lead fell off while slitting the catheter.Physician stated that the catheter's hemostasis valve was stiffer than usual so cutting.No adverse patient effects were reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.This supplemental correction report was created due to initial report was sent in error.Boston scientific does not have reporting responsibilities on this record.
Event or Problem Description
It was reported that this catheter was discontinued to use due to hemostasis valve broke and the back flow of blood could not be stopped.The lead fell off while slitting the catheter.Physician stated that the catheter's hemostasis valve was stiffer than usual so cutting.No adverse patient effects were reported.

• Brand Name: DELIVERY CATHETER SSPC3
• Common Device Name: CATHETER
• 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: 19684505
• Report Number: 2124215-2024-41653
• Device Sequence Number: 16922988
• Product Code: DQY
• UDI-Device Identifier: 00810024671830
• UDI-Public: 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: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2024

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: 11/06/2025
• Device Model Number: 9183
• Device Catalogue Number: 9183
• Device Lot Number: CL12237
• 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: 06/10/2024
• Supplement Date Received by Manufacturer: 07/14/2024
• Initial Report FDA Received Date: 07/05/2024
• Supplement Report FDA Received Date: 07/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2023
• 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