MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPORT ISP M.R.I. IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 1808060

Device Problems Expulsion (2933); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 03/24/2023

Event Type  Injury  

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 sometime post a port placement, the patient allegedly experienced infection.It was further reported that the patient allegedly developed with thrombosis.The current status of the patient is unknown.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the physical device was not returned for evaluation.The medical records allege that, for a patient bard powerport isp mri port was implanted for cancer treatment.Blunt dissection was used to create a subcutaneous pocket for the port reservoir.A metal tunneler was then utilized to tunnel the port catheter from the subcutaneous pocket to the neck venotomy site.The port catheter was connected to the reservoir and it was checked for leakage.The port pocket was then irrigated and the port reservoir was placed into the pocket.The catheter was then cut to length.A peel away sheath was then placed over wire under fluoroscopic visualization.The port catheter was then placed to the peel-away sheath and positioned with the tip of the catheter at the level of superior vena cava/right atrium junction.The port catheter has a smooth course.The port reservoir was checked and subsequently flushed with heparin.The skin was closed.The patient tolerated the procedure without difficulty and remained in stable condition.The port-a-catheter was ready for use.Approximately one year after dye flow study under fluoroscopy was performed.The patient¿s port was injected with contrast and multiple spot images were obtained.Impression included moderate-sized fibrin sheath with contrast pooling at the distal aspect of the catheter raising concern for some underlying nonocclusive thrombus.After two months, computed tomography chest, abdomen and pelvis with contrast showed possible thrombus in the right internal jugular vein adjacent to the port-a-cath.Six months fourteen days later, removal of port was performed due to eroded port.Using blunt dissection the chest port was freed from adhesions and removed along with the entire tunneled venous catheter.The procedure was completed without any apparent complication.Successful removal of chest port and tunneled catheter with small purulent pocket beneath the port.Based on the medical review the reported port eroded confirmed by the investigation.Additionally, it can be confirmed that the patient experienced thrombosis 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: d4 (expiry date: 12/2022), g2, g3, h6 (method).H11: b3, b5, d4 (medical device lot number), h6 (device, result).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 through the litigation process that one year, one month and fourteen days post a port placement via the internal jugular vein, the patient allegedly developed infection.It was further reported that the patient allegedly experience thrombosis in the right internal jugular vein adjacent to the port.Furthermore, the port was allegedly found to be eroded and was removed from the patient.The current status of the patient is unknown.

• Brand Name: POWERPORT ISP M.R.I. IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 8F
• 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: 19095187
• MDR Text Key: 339988695
• Report Number: 3006260740-2024-01696
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741027031
• UDI-Public: (01)00801741027031
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063377
• 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,Followup
• Report Date: 05/09/2024

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: 1808060
• Device Lot Number: REFV3937
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/22/2024
• Initial Date FDA Received: 04/12/2024
• Supplement Dates Manufacturer Received: 05/06/2024
• Supplement Dates FDA Received: 05/28/2024
• Was Device Evaluated by Manufacturer?: No
• 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