MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 UNKNOWN PORT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number UNKNOWN PORT

Device Problem Malposition of Device (2616)

Patient Problems Pulmonary Embolism (1498); Thrombosis/Thrombus (4440)

Event Date 05/19/2020

Event Type  Injury  

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Post port placement ultrasound revealed pulmonary embolism along with a right internal jugular deep vein thrombosis.The patient also presented with mild functioning of pre-existing right chest wall infuse-a-port.Around one day later, placement of new 8-french power injectable central venous port via left internal jugular approach using ultrasound and fluoroscopic guidance and removal of existing non-functioning, malpositioned right internal jugular port was performed.The existing right internal jugular port infuse-a-port catheter had become malpositioned, with the tubing looped back into the right internal jugular vein.Removal of the old port and placement of a new port has been requested.New port was implanted successfully, spot fluoro image obtained following placement showed the catheter tip in good position in the right atrium.The port was flushed and heparinized in the usual manner.Around one year and eight months post new port placement, the infuse-a-port was accessed in the usual sterile fashion.Injecting contrast was extreme in leigh difficult, and after injection there was a small amount of contrast outlining the infuse-a-port, consistent with fracture of the port catheter or the diaphragm.Around four days later, malfunctioning infus a port fractured was planned for removal.To maintain the current access in the left internal jugular, the port was cut catheter and attempted to advance the wire through the catheter.However, the wires were not able to be advanced through the catheter.On closer inspection, the catheter tubing appeared to have a bluish gray thick substance lining the wall of the catheter and significantly decreased flow through the port.The port was then removed in toto.Further inspection of the port demonstrated that the reservoir within the port had partially eroded with this similar blue/gray material.Next, access was obtained to the left internal jugular vein with a micro puncture kit.There was some difficulty in advancing wire centrally and a central venogram was performed, demonstrating patent central veins.Eventually, the microwire was able to be advanced into the inferior vena cava.The new port was then placed.The port aspirated and flushed normally.The port incision and access sites were closed.The patient tolerated procedure well without immediate complication.Therefore, the investigation is confirmed for the reported malposition of port.Additionally, it can be confirmed patient experienced pe and thrombosis post port placement.However, the relationship between the port is unknown.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.H11: 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.H3 other text : device not returned.

Event Description

It was reported through litigation process that sometime post a port placement, the catheter allegedly malpositioned.The patient was allegedly diagnosed with pulmonary embolism and deep vein thrombosis.The port was removed from the patient.However, the current status of the patient was unknown.

• Brand Name: UNKNOWN PORT
• 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: 18892517
• MDR Text Key: 337510909
• Report Number: 3006260740-2024-01039
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/26/2024

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: UNKNOWN PORT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/22/2024
• Initial Date FDA Received: 03/13/2024
• 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: 53 YR
• Patient Sex: Female