MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPORT MRI ISP 8F GROSHONG CATHETER; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number 9808560

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/30/2018

Event Type  malfunction  

Manufacturer Narrative

No medical records and no medical images were provided to the manufacturer.The lot number for the device was not provided, therefore, the device history records were not reviewed.The return of the device is pending.The investigation is currently underway.

Event Description

It was reported that approximately two years post port placement during infusion of anti-cancer agent, the catheter allegedly leaked.It was further reported that the infusion was stopped and a ct examination identified a subcutaneous leak of contrast.Reportedly, the port system was removed.There was no reported patient injury.

Event Description

It was reported that approximately two years post port placement within the right subclavian vein during infusion of anti-cancer agent, the catheter allegedly leaked.It was further reported that the infusion was stopped and a ct examination identified a subcutaneous leak of contrast.Reportedly, the port system was removed.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: a lot history review could not be performed as the lot number is unknown.Investigation summary: received one powerport isp mri with 8 fr groshong catheter for evaluation.Visual inspection identified one partial circumferential split in the catheter.The split is characterized by necking catheter and granular surface.Therefore, the investigation is confirmed for a subcutaneous leak without embolism.The definitive root cause could not be determined based upon the available information.It is unknown if patient and/or procedural issues contributed to the reported event.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.

• Brand Name: POWERPORT MRI ISP 8F GROSHONG CATHETER
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8190870
• MDR Text Key: 131207765
• Report Number: 3006260740-2018-03733
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741027512
• UDI-Public: (01)00801741027512
• Combination Product (y/n): N
• PMA/PMN Number: K063377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9808560
• Device Catalogue Number: 9808560
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2018
• Date Manufacturer Received: 02/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1