MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. POWERPICC PROVENA FT CATHETER WITH SOLO VALVE TECHNOLOGY; CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS

Model Number	S1295108FD5
Health Effect - Clinical Codes	Chest Pain (1776); Dyspnea (1816); Nausea (1970); Vomiting (2144); Foreign Body In Patient (2687)
Date of Event	08/20/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Picc insertion on (b)(6) 2021.X-ray of picc line placement performed and no foreign body notes.Patient was discharged home with on (b)(6) 2021.Returned to emergency room with intractable nausea and vomiting.She also had reported some sob and chest pain for past several days prior.Ct scan ordered of chest and abdomen.A foreign body noted in heart on ct scan.A chest x-ray was obtained and confirmed foreign body in right ventricle of heart.Heart cauterizations performed to remove the foreign body.Cardiologist was able to remove the foreign body which is believed to be a piece of the picc insertion guidewire.The foreign body approximately 1 to 1 1/2 inches in length.Foreign body was placed in a container and transported to laboratory for further inspection.Fda safety report id # (b)(4).

• Brand Name: POWERPICC PROVENA FT CATHETER WITH SOLO VALVE TECHNOLOGY
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.; salt lake city UT 84116
• MDR Report Key: 12438741
• Report Number: MW5103758
• Device Sequence Number: 11746314
• Product Code: LJS
• UDI-Device Identifier: 00801741155215
• UDI-Public: 00801741155215
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/02/2021

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: 07/31/2022
• Device Model Number: S1295108FD5
• Device Catalogue Number: S1295108FDS
• Device Lot Number: REFS2677
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 27 YR
• Patient Weight: 55