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 Break (1069); Detachment of Device or Device Component (2907)

Patient Problems Palpitations (2467); Foreign Body In Patient (2687)

Event Date 10/19/2018

Event Type  malfunction  

Event Description

Bard power port originally placed on [date redacted].Eight months later, patient presented to the emergency department with palpitations, chest x-ray revealed a portion of the port had broken loose and was retained in the left hilum of the pulmonary artery.Patient was taken to the catheter lab and the foreign body was removed.On [date redacted],the patient was taken to the operating room and the rest of the port was removed and replaced with a new one.

• 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: 8068786
• MDR Text Key: 127122963
• Report Number: 8068786
• 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: 10/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1808560
• Device Catalogue Number: 1808560
• Device Lot Number: REB21703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/25/2018
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1