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

Model Number 1808000

Device Problems Migration or Expulsion of Device (1395); Detachment of Device or Device Component (2907); Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/21/2020

Event Type  malfunction  

Event Description

The patient received chemotherapy treatments thru this port.On day of treatment, infusion nurse accessed port and upon accessing "felt different and blood upon aspiration was very dark." patient did not receive chemotherapy that day.Went to the operating room for a port exploration.Upon imaging at the start of case before any manipulation, per the surgeon - observed a piece of port in the right ventricle.Patient was then woken up from anesthesia and transferred to interventional radiology.In the interventional radiology area, the fragmented piece was removed and sequestered in pathology.One week later, the patient returned to the operating room - had the complete port reported in this event report removed.A new port then was placed.Port exchange was complete.Port secured in pathology.Patient did not tolerate harm in any of the above.

• Brand Name: POWERPORT 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: 11154312
• MDR Text Key: 226289182
• Report Number: 11154312
• 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: 01/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1808000
• Device Catalogue Number: 1808000
• Device Lot Number: REEP1854
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/07/2021
• Event Location: Hospital
• Date Report to Manufacturer: 01/12/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/12/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1