MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. POWERPORT ISP M.R.I. IMPLANTABLE PORT GROSHONG; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number 1808560

Device Problems Fracture (1260); Material Fragmentation (1261)

Patient Problems Perforation (2001); Chemical Exposure (2570); Foreign Body In Patient (2687)

Event Date 01/30/2023

Event Type  malfunction  

Event Description

Patient with left subclavian groshong port placed [date redacted] by surgeon in clinic setting.Port was malfunctioning during recent inpatient stay, and port catheter check from [date redacted] showed catheter perforation near the subclavian vein insertion site.Leaking contrast into soft tissue.Due to scheduling, decision made to remove catheter at a later time and just make sure the port wasn't used in the interim.Port was attempted to be removed by outpatient surgery on [date redacted], but catheter perforation became a complete catheter fracture with a retained fragment located inside the body.General surgery had to transfer the patient to vascular interventional radiology urgently for retained foreign body retrieval.Catheter snared and removed without further fragmentation.Photos available.Ir supervisor plans to speak with bard and arrange return.

• Brand Name: POWERPORT ISP M.R.I. IMPLANTABLE PORT GROSHONG
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.; 605 north 5600 west; salt lake city UT 84116
• MDR Report Key: 16322358
• MDR Text Key: 309084277
• Report Number: 16322358
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1808560
• Device Catalogue Number: 1808560
• Device Lot Number: REEX1379
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/31/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/08/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 13870 DA
• Patient Sex: Female