MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. POWERPORT CLEARVUE SLIM IMPLANTABLE PORT; PORT CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number 1616000

Device Problems Crack (1135); Migration or Expulsion of Device (1395); Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 01/21/2021

Event Type  malfunction  

Event Description

Powerport¿ clearvue¿ slim implantable port stopped functioning as intended after approximately 11 months of use.The decision was made to remove and replace the port.Per provider's notes when replacing the port: "port check demonstrating retraction of the catheter tip into the junction of the superior vena cava (svc) and subclavian vein as well as extravasation of contrast along the midportion of the catheter concerning for a crack in the catheter.There is also a fibrin sheath along the catheter within the jugular vein.The catheter should not be used." the catheter was removed and a new medi-port was placed on the contralateral side.

• Brand Name: POWERPORT CLEARVUE SLIM 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: 13167840
• MDR Text Key: 283256479
• Report Number: 13167840
• 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: 01/03/2022

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 Model Number: 1616000
• Device Catalogue Number: 1616000
• Device Lot Number: REET2765
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/03/2022
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/05/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/05/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22265 DA
• Patient Sex: Male
• Patient Weight: 123 KG