MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPORT SLIM IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 1716070

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

Patient Problems Pulmonary Embolism (1498); Pain (1994); Thrombosis/Thrombus (4440)

Event Date 01/21/2022

Event Type  Injury  

Event Description

It was reported through litigation process that sometime post a port placement, the patient allegedly developed thrombosis.However, 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 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 seven months and four days post a port placement via the subclavian vein, the patient allegedly experienced pain and swelling in the left arm and was diagnosed with deep vein thrombosis in the left internal jugular, subclavian and likely axillary veins.It was further reported that patient was diagnosed with pulmonary embolism.Reportedly, the port was removed.However, 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 device was not returned for evaluation.Medical records were received and reviewed.The review states the bard implantable port for chemotherapy which was implanted at the subclavian vein with help of guide wire by using the seldinger technique.With the help of fluoroscopy, the port was placed in the subcutaneous pocket before trimming the catheter, further it was flushed with dilute heparinized saline.Under the fluoroscopy the tip placement was confirmed at the superior vena cava/right atrial junction.Approximately after seven months, the patient was admitted for left arm swelling and pain.Under the ultrasound arterial duplex of left arm shows a deep venous thrombosis in the left internal jugular, subclavian and likely axillary veins and computed tomography angiogram of chest shows a subsegmental pulmonary basilar left lower lobe, further chest x-ray showed the wall of left chest with the catheter tip in the mid svc.Patient was then admitted and started heparin.Approximately after eleven months later on the completion of radiation chemotherapy the port was planned to remove, and it was removed by left tunneled central venous catheter with subcutaneous port.Port-a-cath was visually inspected at the posterior aspect of cavity, finally the port was explanted from the all the subcutaneous attachments.Therefore, the investigation is inconclusive as no objective evidence for the reported deficiency with the port in the submitted medical record review.Additionally, it can be confirmed that the patient experienced deep venous thrombosis, pain and swelling.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: 11/2024), g2, g3, h6 (patient, method) h11: b2, b3, b5, d4 (medical device lot number) 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: POWERPORT SLIM IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 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: 18738793
• MDR Text Key: 335752929
• Report Number: 3006260740-2024-00671
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741026768
• UDI-Public: (01)00801741026768
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072549
• 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: 03/15/2024

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: 1716070
• Device Lot Number: REEV0983
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/24/2024
• Initial Date FDA Received: 02/20/2024
• Supplement Dates Manufacturer Received: 03/11/2024
• 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): Life Threatening; Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White