MAUDE Adverse Event Report: CENTERPOINT SYSTEMS LLC CPS LOCATOR 3D DELIVERY CATHETER; PERCUTANEOUS CATHETER

Model Number	DS2C200-42
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
When the doctor inserted the guiding dilator, there was resistance and a mesh-like tissue was attached to the tip of the dilator.Doctor's opinion: product defect.
Additional Manufacturer Narrative
The distributor provided a picture of the dilator with "mesh-like tissue." it was apparent from the picture that mesh-like substance was the braid-tail that is typically cut-off during the manufacturing process.It is likely that the braid-tail was folded into the catheter during a mandrel removal process.Center point did a thorough review of the production records to determine if there were any abnormal occurences during the manufacturing process.All production records indicated there was no problem during manufacturing, thereby demonstrating this is most likely an isolated occurrence.The device was not returned to the manufacturer therefore no final determination could be made.Center point immediately made production personnel aware and completed the investigation with all the available information.Although there was no patient involvement during this event, although it is highly unlikely that this braid wire could be exposed to the patient, center point is reporting this event out of caution as exposed braidwire such as that included in the braid-tail that was mistakingly left in the shaft of the catheter could cause injury to the patient.No further action, including remedial actions (e.G.Recall), are required at this time.

• Brand Name: CPS LOCATOR 3D DELIVERY CATHETER
• Common Device Name: PERCUTANEOUS CATHETER
• 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
• MDR Report Key: 20325336
• Report Number: 3015970743-2024-00003
• Device Sequence Number: 12787116
• Product Code: DQY
• UDI-Device Identifier: 00810024670123
• UDI-Public: 00810024670123
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/26/2024

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: 03/19/2025
• Device Model Number: DS2C200-42
• Device Lot Number: CL12530
• 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: 08/28/2024
• Initial Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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