MAUDE Adverse Event Report: CENTERPOINT SYSTEMS LLC CPS LOCATOR 3D DELIVERY CATHETER; Catheter, percutaneous

Model Number	DS2C200-42
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Right sided dual chamber pacemaker with left bundle branch area pacing.Once access was obtained the physician shaped the cps locator with the dilator inside.He introduced the cps locator with the dilator, then removed the dilator and went in with the lead under fluoro and noticed that the cps locator was broken off into the body.The physician thinks that since the turne of svc was almost 110 degrees that when the introducer was removed the cps locator broke.There was about 5 inches of cps locator left in the body that was removed with a snare.
Additional Manufacturer Narrative
Upon initial receipt of the complaint, centerpoint systems reviewed the production lot history record and the information provided by the healthcare professional and distributor.Initial investigation did not result in any identified root causes.Further information was requested, including the return of the device.Additional investigation results, if any, will be reported in a follow-up.Per the information provided by the third party (distributor), there was no adverse impact on the health of the patient.

• Brand Name: CPS LOCATOR 3D DELIVERY CATHETER
• Common Device Name: Catheter, percutaneous
• Manufacturer (Section D): CENTERPOINT SYSTEMS LLC; 3338 parkway blvd; west valley city UT 84119
• Manufacturer Contact: teresa clark ; 3338 parkway blvd; west valley city, UT 84119 ; 8778480828
• MDR Report Key: 19563563
• Report Number: 3015970743-2024-00001
• Device Sequence Number: 20708243
• Product Code: DQY
• UDI-Device Identifier: 00810024670123
• UDI-Public: 00810024670123
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K230363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/18/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/29/2025
• Device Model Number: DS2C200-42
• Device Lot Number: CL12372
• 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: 05/24/2024
• Initial Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/29/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 87 YR
• Patient Sex: Male
• Patient Weight: 97 KG