MAUDE Adverse Event Report: BARD POWERPOINT MRI ISP W / 8FR GROSHONG CATHETER; PORT AND CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 1808560

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/17/2017

Event Type  malfunction  

Event Description

A port placed a month or so ago with almost constant issues.Cxr within normal limits, but contrast administered through port on (b)(6) 2017 revealed right-sided port with distal tip overlying the right brachiocephalic/svc junction with free flow contrast through infusion port and contrast exiting port catheter proximal to its distal tip.This is suggestive of a fibrin sheath covering the tip.Blood cannot be withdrawn from the catheter.

• Brand Name: POWERPOINT MRI ISP W / 8FR GROSHONG CATHETER
• Type of Device: PORT AND CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD
• MDR Report Key: 6986507
• MDR Text Key: 90670096
• Report Number: MW5073008
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: 1808560
• Device Lot Number: REBT1582
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 79 YR