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 4808061

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

Patient Problems Bacterial Infection (1735); Endocarditis (1834); Unspecified Infection (1930); Sepsis (2067); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 10/17/2019

Event Type  Injury  

Event Description

It was reported through the litigation process that sometimes post a port placement, the patient allegedly developed infection.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 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.

Manufacturer Narrative

H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.H10: b2, d4 (expiry date: 11/2019), g2, g3 h11: b3, b5, d1, d4, h6 (patient, result, conclusion).

Event Description

It was reported through litigation process that one year and one day post a port placement via the right subclavian vein, the patient was diagnosed with bacterial infection with the blood culture resulted positive for saphylococcus epidermidis.It was further reported that the patient was allegedly diagnosed with bacteremia and septicemia due to methicillin resistant staphylococcus aureus and staphylococcus endocarditis.It was also reported that the patient allegedly experienced aortic valve endocarditis with vegetation and leaflet perforation resulted in severe aortic insufficiency secondary to bacteremia.Furthermore, the patient underwent aortic valve replacement surgery for severe aortic insufficiency secondary to staphylococcus epidermidis endocarditis.Reportedly, the infected port was removed and patient was continued on intravenous antibiotic therapy.However, 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: 19169903
• MDR Text Key: 340898512
• Report Number: 3006260740-2024-01874
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741027338
• UDI-Public: (01)00801741027338
• 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,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/30/2024

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: 4808061
• Device Lot Number: RECT0973
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/08/2024
• Initial Date FDA Received: 04/24/2024
• Supplement Dates Manufacturer Received: 04/25/2024
• Supplement Dates FDA Received: 05/22/2024
• 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; Life Threatening
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Race: White