MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 TITANIUM IMPLANTABLE PORT, HICKMAN SINGLE-LUMEN, 9.6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 0602230

Device Problems Fracture (1260); Material Separation (1562); Migration (4003)

Patient Problems Chest Pain (1776); Foreign Body In Patient (2687); Unspecified Tissue Injury (4559)

Event Date 10/25/2022

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history records could not 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 about seven years post port placement for purposes of gamma globulin injections, the catheter was allegedly found to be fractured when the port was removed.It was further reported that the fragment of catheter migrated and left in artery causing tissue damage.The current status of the patient is unknown.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the sample was not returned for evaluation.However, a medical record was provided for review.The investigation is confirmed for the reported catheter fracture, material separation and migration issues, as after two years of removal of the port, a computed tomography of thorax was performed and the study showed retained catheter fragment along the posterior aspect of the upper superior vena cava and showed severe stenosis versus occlusion of the lower superior vena cava with venous collateralization.A definitive root cause could not be determined based upon the available information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.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.

Event Description

It was reported that about seven years post port placement for purposes of gamma globulin injections, the catheter was allegedly found to be fractured when the port was removed.It was further reported that the fragment of catheter migrated and left in artery causing tissue damage.Furthermore, a computed tomographic examination confirmed retained catheter fragment along the posterior aspect of the upper superior vena cava.Reportedly, the patient experienced chest pain.The current status of the patient is unknown.

Manufacturer Narrative

Investigation summary: the physical device was not returned for evaluation.Medical record were provided and reviewed.The medical record alleges a mediport catheter was inserted for hemo access for gamma globulin therapy.The incision site was identified between the right sternocleidomastoid muscle and j wire was inserted into the needle at the level of inferior versa cava with the help of fluoroscope.Further the needle was removed with the wire and port pocket was created in the right upper chest above the pectoralis fascia.The silastic catheter was tunneled form the pocket site to the vein insertion site and it was trimmed to required length.With the help of fluoroscopic guidance the sheet dilator was in inserted into the internal jugular vein and the dilator was removed with the wire and the sheet was inserted through the pillowy sheet which was further removed a gentle curve on the catheter was created and further the catheter was aspirated and flushed using an injectable saline and then the catheter was trimmed at the port side connected to the port and to the lower lock adapter.The port was then tracked to the pectoralis fascia and using a huber tip needle percutaneously come on it was able to have spread through the system and there was a free flow of injectable saline through the system the patient tolerated the procedural without any complication.Approximately 8 years and ten months later the mediport was no longer needed and was planned to remove.The removal procedure was taken place by opening the packet and there was no sign of infection further the the port was dissected free from the packet and the port catheter was removed intact.Manual pressure held for hemostasis and the packet was irrigated and the port packet was closed, the procedure was completed without any complication.Approximately a month later of port removal a computer tomography of thorax with the contracts rebuilt the retained catheter fragment in the upper superior vena cava.As the medical record confirms the catheter fracture, separation and migration and the investigation was also confirmed the same reported device malfunction.However there is no objective evidence of chest pain couldn't be noted in the submitted medical record review.Hence, the relationship to the port is unknown.Furthermore, the clinical condition alleged in the complaint cannot be confirmed.Based upon the available information, the definitive root cause is unknown.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.(expiration date: 10/2015) section a through f ¿ the information provided by bd represents all 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.

Event Description

It was reported through the litigation process that eleven years and three months post a port placement via the internal jugular vein, for the purpose of gamma globulin injection, the catheter was allegedly found to be fractured upon removal.It was further reported that the fractured catheter fragment had allegedly migrated and left in the artery causing tissue damage.Furthermore, a computed tomographic examination confirmed retained catheter fragment along the posterior aspect of the upper superior vena cava and the patient allegedly experienced chest pain.Reportedly, the port and catheter were removed intact.The current status of the patient is unknown.

• Brand Name: TITANIUM IMPLANTABLE PORT, HICKMAN SINGLE-LUMEN, 9.6F
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 16359850
• MDR Text Key: 309366620
• Report Number: 3006260740-2023-00418
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741025563
• UDI-Public: (01)00801741025563
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/30/2024

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 Catalogue Number: 0602230
• Device Lot Number: REUI1257
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/17/2023
• Initial Date FDA Received: 02/12/2023
• Supplement Dates Manufacturer Received: 05/02/2023; 04/18/2024
• Supplement Dates FDA Received: 05/04/2023; 05/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female