MAUDE Adverse Event Report: BARDPORT PORT-A-CATH; PORTACATH

Lot Number REXJ1199

Device Problems Break (1069); Occlusion Within Device (1423)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/01/2015

Event Type  Injury  

Event Description

Bardport lot #rexj1199 reference # (b)(4) was implanted on (b)(6) 2014 in the patient's left subclavian.It became occluded while attempting to access on (b)(6) 2015.Imaging showed that a portion had broken off requiring surgery to remove due to being lodged in the inferior hepatic vein.The patient was receiving care at (b)(6) who notified (b)(6) as the implanting facility.Removed after 341 days.

• Brand Name: PORT-A-CATH
• Type of Device: PORTACATH
• Manufacturer (Section D): BARDPORT; nashville TN 37208
• MDR Report Key: 4684319
• MDR Text Key: 20153568
• Report Number: MW5042062
• Device Sequence Number: 1
• Product Code: LJT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 04/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: REXJ1199
• Other Device ID Number: 0602660
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 129