MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPORT DUO M.R.I. IMPLANTABLE PORT, CHRONOFLEX DUAL-LUMEN, 9.5F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 1829500

Device Problems Difficult to Flush (1251); Suction Problem (2170); Obstruction of Flow (2423); Migration (4003)

Patient Problems Hematoma (1884); Unspecified Infection (1930); Thrombosis/Thrombus (4440)

Event Date 08/02/2023

Event Type  Injury  

Event Description

It was reported through the litigation process that sometimes post port placement via the right internal jugular vein, the patient had allegedly experienced difficulties including but not limited to infection, clotting and migration.Reportedly, the port was removed.The current status of the patient is unknown.

Manufacturer Narrative

H10: 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.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.H3 other text : device not returned.

Event Description

It was reported through the litigation process that sometimes post a port placement via the right internal jugular vein, the tip of the port was allegedly likely found to be too long and was terminated in the right ventricle.It was further reported that the port was non-functioning and was allegedly clotted.It was also reported that the patient was diagnosed with thrombosis of right internal jugular vein around the port along with hematoma of chest wall.Furthermore, the patient was diagnosed with catheter related septic thrombophlebitis.Reportedly, antibiotics were provided and the port was removed.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 received and reviewed.Per the review, the bard mri powerport duo was implanted on exchange to previous port and it was implanted to subcutaneous tissue of right internal jugular vein under ultrasound guidance, the catheter was attached to the port reservoir and both was flushed.Approximately after fifteen days the patient had intermittent palpitations and a chest x-ray was showed tip of the port was likely too long, terminating in the right ventricle.Three days later a computed tomography of chest performed for right chest port, severe pain, concern for infection, thrombosis, rapid heart rate, pain down right arm and possible port infection, further it appeared the distal right internal jugular vein not well opacified and possible mild associated inflammation and fluid.Further the computed tomography of neck showed the decreased density within the right internal jugular vein extending from its junction with the right internal jugular vein catheter superiorly with fluid in the adjacent soft tissues which reflected thrombophlebitis and the thrombus appeared to be occlusive, it was also observed that within the subcutaneous soft tissues of the right upper chest wit low density lesion with peripheral enhancement.Furthermore the chest x-ray showed the new presumed right internal jugular multi lumen port-a-cath with tip at the anticipated junction of the superior vena cava right atrium and considerations include abscess and hematoma.The discharge summary reports the patient was diagnosed with thrombosis of right internal jugular vein along with hematoma of chest wall and it was also suspected that the palpitations were actually not coming from the port but rather from the thrombus that was adherent to the port.Approximately after three months the implanted port was scheduled for removal and the port and the catheter was disconnected and removed successfully.Therefore, the investigation is inconclusive as no objective evidence for the the reported deficiency with the port in the submitted medical record review.Additionally, it can be confirmed that the patient experienced thrombosis, hematoma and infection.However, 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.H10: g2, g3, h6 (patient, device, method).H11: b5, d1, d4 (medical device catalog number).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.H3 other text : device not returned.

• Brand Name: POWERPORT DUO M.R.I. IMPLANTABLE PORT, CHRONOFLEX DUAL-LUMEN, 9.5F
• 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: 17641448
• MDR Text Key: 322162617
• Report Number: 3006260740-2023-03738
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741027185
• UDI-Public: (01)00801741027185
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090512
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/14/2024

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: 1829500
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/02/2023
• Initial Date FDA Received: 08/29/2023
• Supplement Dates Manufacturer Received: 03/13/2024
• Supplement Dates FDA Received: 03/25/2024
• 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: 40 YR
• Patient Sex: Female