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

Device Problem Material Fragmentation (1261)

Patient Problems Chest Pain (1776); Dyspnea (1816); Nausea (1970); Vomiting (2144); Foreign Body In Patient (2687)

Event Date 08/20/2021

Event Type  Injury  

Event 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
• Type of Device: 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
• MDR Text Key: 270770945
• Report Number: MW5103758
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741155215
• UDI-Public: 00801741155215
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 27 YR
• Patient Weight: 55