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

Catalog Number	1608362
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Endocarditis (1834); Unspecified Infection (1930)
Date of Event	02/24/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported through litigation process that sometime post a port placement, the patient allegedly developed infection.However, the current status of the patient is unknown.
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records will 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.H10: d4 (expiration date: 07/2020).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.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the physical device was not returned for evaluation.Medical record were provided for review.The medical record alleges that implant port was implanted for the patient with the history of breast cancer the implant was take place by making a report packet dissected at the chest and their vessel dilator and appealability sheet was passed over the wire and advanced further the wire was removed and the dilator was removed leaving the sheet in place through this the catheter position was advanced and the pillowy sheet was then further removed leaving the catheter in place.With the help of fluoroscopic guidance the catheter was then retracted until it stripped played within the lumen of the superior vena cava and the catheter was fashioned to attach with the port-a-cath in the usual fashion lock with the locking device over the net further the port was assessed through the skin with the huber needle aspirated with the good flow and flushed with the injectable saline, the final fluoroscopic conforms the placement of catheter type within the lumen of superior vena cava with no bends or kinks and the port was assessed on the final time through the skin with the human needle aspirated with the good flow flushed with the injectable saline and locked with the 3000 unit of heparin.The procedure went well.Approximately seven months later a plan of removing the chess board was made due to the history of endocarditis and bacteremia and the removal procedure was taken place by using a blunt and sharp dissection and free the port, the pseudo capsule that formed in the packet was dissected as well and the port packet was copiously irrigated with the saline and there was no gross evidence of infection at the end the port packet was closed and the procedure went well.On the same day the catheter tip was sent for a culture and the blood culture samples were collected after six days later the culture confirmed the bacterial endocarditis and numerous culture of cocci were seen with the consistence with the staphylococcus in the patients blood culture.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 bacterial endocarditis, staphylococcus 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 (expiration date: 07/2020), g2, g3, h6 (method).H11: b3, b5, h6 (patient, result).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 approximately seven months and twelve days post a port placement via the left subclavian vein, the patient allegedly developed bacterial endocarditis and staphylococcus infection.Reportedly, the port was removed from the patient.However, the current status of the patient is unknown.

• Brand Name: POWERPORT CLEARVUE ISP 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: 19094425
• Report Number: 3006260740-2024-01690
• Device Sequence Number: 18076807
• Product Code: LJT
• UDI-Device Identifier: 00801741108082
• UDI-Public: (01)00801741108082
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K122899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2024

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: 1608362
• Device Lot Number: REDQ2847
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/19/2024
• Supplement Date Received by Manufacturer: 05/20/2024
• Initial Report FDA Received Date: 04/12/2024
• Supplement Report FDA Received Date: 05/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/17/2019
• 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: 54 YR
• Patient Sex: Female