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

Model Number 1809660

Device Problems Migration or Expulsion of Device (1395); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 10/20/2021

Event Type  Injury  

Event Description

Physician was placing a port on the right side.Physician created the pocket for the port.After dilating with the first wire, he progressed to the next wire.This wire fell into the vascular system.It is unclear if the wire broke or slipped off the device.The wire migrated into the pelvic vascular system.Interventional radiology was able to remove the wire through the groin.The port was placed.

• 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: 13108422
• MDR Text Key: 282902016
• Report Number: 13108422
• 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: 12/03/2021,10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1809660
• Device Catalogue Number: 1809660
• Device Lot Number: REFR4198
• 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: 12/03/2021
• Event Location: Hospital
• Date Report to Manufacturer: 12/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 23725 DA
• Patient Sex: Male
• Patient Weight: 183 KG