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 1608062

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

Patient Problems Bacterial Infection (1735); Stroke/CVA (1770); Rash (2033)

Event Date 03/25/2024

Event Type  Injury  

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 medical records allege that, patient with a history of bacteremia and concern for port infection underwent removal of infected port under fluoroscopically guidance.By the sharp and blunt dissection, the catheter component of the port was localized and externalized.The fibrous tissue surrounding the port reservoir was subsequently incised and the port was removed in its entirety.The tip of the port was cut and sent to pathology for further evaluation.After one day of port removal, port-a-cath tip culture report showed positive for methicillin resistance staphylococcus aureus.Approximately two years nine months post placement of port for recurrent urinary tract infection and venous access, patient presented to the emergency department for concern for infection of port-a-cath.Patient had an infected line when it was on the right but his current power port on the left.Patient had rash on chest, and it suspects that there is an infection there as the urine is look cloudier.Chest x-ray was performed which showed left sided chest port is seen with its tip over the right atrium.After one month twenty-six days patient presented for portogram procedure to eval the port-a-cath.The study showed normal port-a-cath venogram, good aspiration and injection.After, four months twenty-nine days patient underwent port removal procedure for port site infection.The port and catheter were removed in entirety.Around one day later central line tip catheter culture report showed positive for methicillin resistance staphylococcus aureus.Twenty days after the culture report, patient underwent port placement procedure for chronic infection with ultrasound and fluoroscopy guidance.Fluoroscopy confirmed with tip at the junction of superior vena cava and right atrium.Around ten months twenty-five days later the port placement urine culture report showed positive for escherichia coli.Therefore, the investigation is inconclusive for the reported adverse event as no objective evidence has been provided to confirm any alleged deficiency with the port.Furthermore, clinical conditions 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: 08/2019).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 two years, nine months and eighteen days post a port placement, the patient allegedly experienced rash on the chest and was diagnosed with catheter related methicillin-resistant staphylococcus aureus infection and was treated with antibiotics.It was further reported that the patient allegedly experienced stroke.Reportedly, the infected port was removed, and new port was implanted.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 medical records allege that, for a patient port placement was planned.An incision was made over the right chest and a subcutaneous pocket was created.The port was secured into the subcutaneous pocket.The catheter was connected to the port, advanced through the subcutaneous tunnel and through the peel away sheath and under fluoroscopic guidance was positioned with the catheter tip in the right atrium.The peel away sheath was removed and the neck incision was closed.A fluoro-spot of the chest was obtained to document the final position of the catheter.The patient tolerated the procedure well without any complications.Approximately after two year six months the patient had bacteremia.So removal of right internal jugular port was performed using a combination of sharp and blunt dissection, the catheter component of the port was localized and externalized.The fibrous tissue surrounding the port reservoir was subsequently incised and the port was removed in its entirety.The tip of the port was cut and sent to pathology for further evaluation.The port pocket was then copiously irrigated.A final fluoroscopic image of the chest demonstrates the complete removal of port with the tip of the picc at the cavoartial junction.The next day port-a-cath tip culture report showed positive for methicillin resistance staphylococcus aureus.Further twenty days later patient underwent placement of port for recurrent urinary tract infection and venous access is required for long term antibiotics.A subcutaneous tunnel was created to the left anterior chest wall.An incision was made over the left chest and a subcutaneous pocket was created.The port was secured into the pocket.The catheter was connected to the port, advanced through the subcutaneous tunnel and through the peel away sheath and under fluoroscopic guidance was positioned with the catheter tip in the right atrium.Around two months six days later during physical examination some redness was noted anterior to the port-a-cath to the left upper chest.The patient had an infected port-a-cath of the right upper chest a few months ago.The patient had to have a picc line placed and was concerned that the port-a-cath may be infected again.After two years seven months patient presented to the emergency department for concern for infection of port-a-cath.Patient had an infected line when it was on the right but his current power port on the left.Patient had rash on chest, and he suspects that there is an infection there as the urine is look more cloudy.He was given dose of ertapenem and ordered for home health.Discharged home and follow blood cultures with strict precautions.Chest x-ray was performed which showed left sided chest port is seen with its tip over the right atrium.The course of the left sided chest port is unchanged from prior study.One month twenty six days later patient presented for portogram procedure to eval the port-a-cath.The study showed normal port-a-cath venogram, good aspiration and injection.Then approximately five months laterpatient underwent port removal procedure for port site infection.An incision was made at the site of the indwelling port.The port was exposed with a combination of sharp and blunt dissection.The port and catheter were removed in entirety.There were no immediate complications.And two days later central line tip catheter culture report showed positive for methicillin resistance staphylococcus aureus.After the twenty days patient underwent port placement procedure for chronic infection with ultrasound and fluoroscopy guidance.An incision was made over the chest wall, a pocket was created, and the catheter was tunneled subcutaneously to the venous access site and trimmed to appropriate length.The port was inserted into the pocket and the catheter was advanced via a peel away sheath into the vein under fluoroscopic guidance.Fluoroscopy confirmed with tip at the junction of superior vena cava and right atrium.Approximately ten months twenty five days later urine culture report showed positive for escherichia coli.Therefore, the investigation is inconclusive as no objective evidence for the the reported deficiency with the port in the submitted medical record review.Additionally, it can be confirmed that the patient experienced rash, infection and stroke.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.(expiration date: 08/2019), 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 Description

It was reported through the litigation process that sometime post a port placement, the patient allegedly experienced rash on the chest and was diagnosed with catheter related methicillin-resistant staphylococcus aureus infection and was treated with antibiotics.It was further reported that the patient allegedly experienced stroke.Reportedly, the infected port was removed, and new port was implanted.The current status of the patient is unknown.

• Brand Name: POWERPORT CLEARVUE ISP 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: 19041989
• MDR Text Key: 339435212
• Report Number: 3006260740-2024-01463
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741026430
• UDI-Public: (01)00801741026430
• 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: 04/22/2024

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: 1608062
• Device Lot Number: RECQ0762
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/25/2024
• Initial Date FDA Received: 04/04/2024
• Supplement Dates Manufacturer Received: 05/08/2024
• Supplement Dates FDA Received: 05/15/2024
• 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
• Patient Age: 58 YR
• Patient Sex: Male