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

Model Number 1808560

Device Problems Entrapment of Device (1212); Fluid/Blood Leak (1250); Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/30/2020

Event Type  Injury  

Event Description

Patient had port placed.Approximately 3 months later, patient to interventional radiology for port removal for leaking port.Angiogram revealed fractured catheter and portion in right atrium.Two unsuccessful attempts for foreign body retrieval and port removal.Referred to ct surgery and after lengthy discussion, the best option now is a conservative one as the catheter is probably epithelialized by now which can result in difficult retrieval and reduce chance of complications.

• Brand Name: POWERPORT ISP M.R.I. IMPLANTABLE PORT
• 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: 10270247
• MDR Text Key: 198700728
• Report Number: 10270247
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 06/29/2020

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?: Yes
• Device Operator: No Information
• Device Model Number: 1808560
• Device Catalogue Number: 1808560
• Device Lot Number: REDV1507
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/29/2020
• Event Location: Other
• Date Report to Manufacturer: 07/14/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 26645 DA
• Patient Weight: 93