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	1808070
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	08/24/2023
Type of Reportable Event	Serious Injury
Additional 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: d4 (expiration date: 08/2024).
Event or Problem Description
It was reported through the litigation process that two months and eighteen days post a port placement in the right atrial superior vena cava junction via the right internal jugular vein, the patient allegedly developed an infection and the blood culture test resulted positive for staphylococcus aureus bacterial infection as a result of the defective infected port.Reportedly, the defective infected port and catheter were removed from the patient.The current status of the patient is unknown.
Additional 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 provided and reviewed.Placement of port was performed for a patient with history of lobular left breast cancer requiring chemotherapy.Prior to the procedure, patency of the right internal jugular vein was confirmed with ultrasound and images recorded.Using real-time ultrasound guidance, the right internal jugular vein was accessed percutaneously, and a guidewire was advanced to the right atrial/superior vena caval junction.A 4 french dilator was then introduced over the guidewire.A skin incision was then made in the right anterior chest wall using blunt dissection.Electrocautery was used to establish hemostasis.The pocket was then irrigated with normal saline solution.The catheter was attached to a powerport.From the pocket and through a subcutaneous tunnel, 8 french catheter was brought and ultimately placed through a peel-away sheath in the right internal jugular vein.Under fluoroscopic guidance, the catheter was advanced to the right atrial/superior vena caval junction.The port was secured in the pocket.The port flushed and aspirated without difficulty.The pocket and venotomy incision were closed.Around three months later, right sided port was noted.Previous incision with edges mostly approximated, but small area that appeared to be opening on medial site was noted.Erythema, warmth, induration was appreciated.Culture results revealed staphylococcus aureus.The same day, removal of port was performed.Through a small incision, the previously placed port was dissected free of the surrounding tissues.The port and attached catheter were removed and inspected.Hemostasis was achieved at the venotomy site with manual compression.The port pocket was inspected and irrigated with saline.The incision was closed with layered absorbable suture and surgical glue.Per the medical record review, it was confirmed the patient had a bacterial infection.However, the relationship between the port and the alleged adverse event is unknown, and there was no device malfunction that was reported or occurred.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 (expiration date: 08/2024).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.
Event or Problem Description
It was reported through the litigation process that two months and eighteen days post a port placement in the right atrial superior vena cava junction via the right internal jugular vein, the patient allegedly developed an infection and the blood culture test resulted positive for staphylococcus aureus bacterial infection as a result of the defective infected port.Reportedly, the defective infected port and catheter were 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
• Common Device Name: 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: 19736800
• Report Number: 3006260740-2024-03713
• Device Sequence Number: 17912523
• Product Code: LJT
• UDI-Device Identifier: 00801741027079
• UDI-Public: (01)00801741027079
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K063377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 1808070
• Device Lot Number: REGX1864
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2024
• Supplement Date Received by Manufacturer: 08/02/2024
• Initial Report FDA Received Date: 07/13/2024
• Supplement Report FDA Received Date: 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female