MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPORT MRI ISP, 8 FR GROSHONG, INTER. SUTURE PLUG, S/L; IMPLANTABLE PORT

Model Number 1808560

Device Problems Break (1069); Fracture (1260); Migration or Expulsion of Device (1395); Material Separation (1562)

Patient Problems Embolism (1829); Device Embedded In Tissue or Plaque (3165)

Event Date 10/05/2018

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.

Event Description

It was reported that approximately seven months post port device implant, upon device removal, the health care provider noticed that the port catheter was allegedly broken and a catheter fragment migrated to the ventricle of the heart; however, the fragment was removed at a later date.It was further reported that approximately nine days post catheter break, ct scan demonstrated another catheter fragment resided in the right hilar region attached to the right pulmonary artery.Reportedly, recent x-ray imaging demonstrated the catheter fragment has moved slightly upward; however, the fragment remains in the patient.The patient status is unknown.

Event Description

It was reported that approximately seven months post port device implant, upon device removal, the health care provider noticed that the port catheter was allegedly broken and a catheter fragment migrated to the ventricle of the heart; however, the fragment was removed at a later date.It was further reported that approximately nine days post catheter break, ct scan demonstrated another catheter fragment resided in the right hilar region attached to the right pulmonary artery.Reportedly, recent x-ray imaging demonstrated the catheter fragment has moved slightly upward; however, the fragment remains in the patient.The patient status is unknown.

Manufacturer Narrative

H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Labeling review: a review of product labeling documentation (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed no inadequacy in the product labeling and is adequate.Investigation summary: a sample evaluation could not be performed, as the device was not returned.However, medical records were provided for review.From the complaint reports, it was determined that a chest x-ray was performed after placement which demonstrated a port in placed on the left side with the tip in the superior vena cava without pneumothorax.The device was removed about 7 months after placement.The port and catheter were removed.Upon inspection of the device, the catheter was incompletely removed with a breach 7 cm from the port or hub.The wound was explored, and scar tissue was removed with attempts to find the edge of the catheter.Port catheter break therefore occurred.Migration to the ventricle of the heart was also reported.This catheter fragment was removed; however, ct scan demonstrated that another linear foreign body, presumably the catheter fragment, about 1.5 inches long, projected along the right hilar region, attached to the right pulmonary artery.This additional catheter fragment remains in the consumer to date.Recent x-ray imaging demonstrated that the catheter fragment had moved slightly upward.Other pertinent information includes that the port was packed down to the fascia with 2-0 prolene sutures and a 2-0 prolene suture was placed in the fascia around the stem of the port to keep the port from buckling up.The complaint is confirmed for catheter breakage, migration, and for material separation, based upon the medical records provided.A root cause could not be determined.It is unknown if patient and/or procedural factors contributed to this event.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• Brand Name: POWERPORT MRI ISP, 8 FR GROSHONG, INTER. SUTURE PLUG, S/L
• Type of Device: IMPLANTABLE PORT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9169854
• MDR Text Key: 161665314
• Report Number: 3006260740-2019-02942
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741027116
• UDI-Public: (01)00801741027116
• Combination Product (y/n): N
• PMA/PMN Number: K063377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 04/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: 1808560
• Device Catalogue Number: 1808560
• Device Lot Number: REBZ1703
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/11/2019
• Initial Date FDA Received: 10/08/2019
• Supplement Dates Manufacturer Received: 04/16/2020
• Supplement Dates FDA Received: 04/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 61 YR
• Patient Weight: 61