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

Catalog Number UNK PORT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chest Pain (1776); Unspecified Infection (1930)

Event Date 08/07/2023

Event Type  Injury  

Event Description

It was reported through the litigation process that three years seven months twenty-two days post a port placement the patient allegedly developed chest pain and had infection.The port was removed and replaced with a new device.The current status of the patient was unknown.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not requested as the lot number reported as unknown.Investigation summary: the physical device was not returned for evaluation.Medical record was received and reviewed.The review shows an unknown port-a-cath was implemented into the patient between the someday of 2006 and approximately after eleven year and seven months later replacement of subcutaneous injection right port was planned.The removal of port was done by an incision, the catheter was cut, and guide wire was advanced into central venous system, this port is an end hole type catheter and still noted to be intact.A peel away catheter was passed over the guide wire, the injectable groshong type catheter was passed over the peel away catheter where, the inlet to the heart, then the peel away catheter was removed.The advanced catheter was further stitched and tied down to the soft tissue.Further an injectable mri type subcutaneous injection port was connected to inserted catheter.The port can be inserted into the pocket, and it was sutured within the pocket to avoid flipping.Then exposed subcutaneous portion was catheter was buried.Port function was tested with saline.Approximately after two year and nine months later the patient was diagnosed with pulmonary embolism.Then after a month it was noted the catheter was broken with the distal catheter fragments coiled at the right atrium.The patient experienced palpitations-secondary to right atrial foreign body/catheter.After two days later electrocardiogram indicates an elevated cardiac enzyme back in non-st elevation myocardial infarction which might related to damage from dislodged catheter.The very next day with identifying the patent internal jugular vein.With the help of recovery snare system advanced to right ventricle the dislodged catheter tip was removed with the help of fluoroscopic guidance.The fluoroscopic shows no residual catheter fragment in the cardiac chamber or chest vascularity.Furthermore, the existing port was removed, and a new port was placed within the right anterior chest wall and catheter tip was positioned within the superior vena cava.The newly placed port was flushed with heparinised without any issue and the patient was comfortable with the without any complications.The next day of newly placed port the patient had an episode of typical chest pain and elevated cardiac enzyme and serial troponin levels with a port-a-cath segment.Two days later patients had concern of infection which might cause by the port-a-cath that was placed in her right subclavian.Approximately three weeks later chest x-ray reveled the port catheter was repositioned and now overlying at the superior vena cava.Approximately after two-year nine month later the patient was complained with infection of subclavian port.After two days the patient continued to have the pain near the right chest wall surrounding the port-a-cath and eventually the pain was tolerable.Then later the implanted port was planned to removal.With the guidance of fluoroscopic the port was explanted and no residual of port nor the catheter left behind in the vessel and the explanted device was sent for culture.After three weeks later a new port was implanted at the left anterior chest wall at the left internal jugular vein, further the fluoroscopic shows the catheter tip at the superior vena cava and port was able to flushed and heparinized.Approximately after a week and five days the patient appeared to have hematoma near the left chemo port.There was no clear evidence of infection at this point.A month later the patient with hematoma over the port-a-cath site and still improving.Therefore, the investigation is inconclusive as no objective evidence for the reported deficiency with the port and catheter in the submitted medical record review.Additionally, it can be confirmed that the patient experienced chest pain, hematoma and infection.However, the relationship to the port and catheter 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.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.

• 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: 18994300
• MDR Text Key: 338825265
• Report Number: 3006260740-2024-01329
• 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: 03/18/2024

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: UNK PORT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/07/2024
• Initial Date FDA Received: 03/28/2024
• 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: 52 YR
• Patient Sex: Female