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

Catalog Number 1808001

Device Problems Fluid/Blood Leak (1250); Deformation Due to Compressive Stress (2889); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Extravasation (1842)

Event Date 07/15/2021

Event Type  Injury  

Event Description

It was reported through the litigation process that three years, two months, and fourteen days post a port placement via the left internal jugular vein, the patient allegedly had a malfunctioned left sided chest port demonstrating extravasation at the level of the jugular vein.Reportedly, the port was removed and replaced.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 device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.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 three years, two months and fourteen days post a port placement via the left internal jugular vein, the patient allegedly had a malfunctioned left sided chest port demonstrating extravasation at the level of the jugular vein.Reportedly, the port was removed and replaced.The current status of the patient is unknown.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately three years and two months post fifth port placement, x ray of port revealed malfunctioned left sided chest port demonstrating extravasation at the level of the jugular vein.The port was planned for removal.Around eleven days later, placement of left subclavian bard powerport and removal of left internal jugular vein powerport was planned.New port was placed successfully.The patient was taken in stable condition.Therefore, the investigation is kept as inconclusive for the reported adverse event as no objective evidence was provided for review.Furthermore, the 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: g3, h6 (method) h11: h6 (device, result, conclusion) 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.

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.The medical records allege that, a placement of right subclavian bard powerport was planned for a patient with unknown medical complication.The left subclavian vain access was attempted but was unsuccessful.After the successful placement, the patient was taken in stable condition.Approximately three months and twenty-five days post first port placement, the patient presented with chest pain.Around five days later, removal of right subclavian port was planned.Pus around the port in the left chest was noted.Around twenty-five days later, placement of right subclavian bard power port was done.Approximately one year and seven months post second port placement, the patient diagnosed with bacteremia and possible endocarditis and so the port removal was planned and completed.Around two months and three days later, placement of right subclavian bard power port was completed successfully.The patient was taken in stable condition.Approximately three years and six months post third port placement, the patient presented with open wound at powerport and presented with drainage from her powerport right chest and also noted to have difficult access.Around eight days later, removal of existing port and new mri powerport placement was planned so an incision was made over the palpable catheter just below the clavicle.The catheter was dissected free, clamped and cut.The wire was passed down the catheter (which was removed) into the subclavian vein.A subcutaneous pocket was made for the bard port reservoir.A dilator and sheath were placed over the guidewire and advance under fluoroscopy.The dilator and guidewire were removed.The catheter portion of the bard port was advanced through the sheath to the distal superior vena cava.The catheter was aspirated and flushed.It was clamped and cut to the proper length, and then connected to the bard port reservoir.The reservoir was placed in the previously made subcutaneous pocket.An incision over the existing port was made.This was removed and cavity irrigated.The patient was taken in stable condition.Fluoroscopy confirmed good placement with the tip of the catheter in the distal superior vena cava.Approximately two years and six months post fourth port placement, malfunctioning right sided chest port is noted.Contrast surrounded the port cavity.Survey of the radiograph does not demonstrate any fractured catheter superimposing any of the pulmonary vessels.On the same day, x ray port revealed that the port was malpositioned, should not be used and should be removed.Around seven days later, the removal of right subclavian vein powerport was planned and placement of left internal jugular vein bard powerport was done successfully.The patient was noted in stable condition.Approximately three years and two months post fifth port placement, x ray of port revealed malfunctioned left sided chest port demonstrating extravasation at the level of the jugular vein.The port was planned for removal.Around eleven days later, placement of left subclavian bard powerport and removal of left internal jugular vein powerport was planned.New port was placed successfully.The patient was taken in stable condition.Therefore, the investigation is kept as inconclusive for the reported catheter kink as no objective evidence was provided for review.Furthermore, the 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: b5, d4 (expiration date: 01/2020), g3 h11: d4 (medical device lot number), h6 (device) 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 litigation process that three years, two months, and fourteen days post a port placement via the left internal jugular vein, the patient allegedly had a malfunctioned left sided chest port demonstrating extravasation at the level of the jugular vein.It was further reported that the catheter was allegedly kinked.Reportedly, the port was removed and replaced with a new port.The current status of the patient is unknown.

• Brand Name: POWERPORT 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: 18826959
• MDR Text Key: 336856618
• Report Number: 3006260740-2024-00892
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741026980
• UDI-Public: (01)00801741026980
• 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,Followup
• Report Date: 04/18/2024

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: 1808001
• Device Lot Number: RECP2519
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/07/2024
• Initial Date FDA Received: 03/04/2024
• Supplement Dates Manufacturer Received: 03/08/2024; 04/16/2024
• Supplement Dates FDA Received: 03/14/2024; 04/26/2024
• 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): Required Intervention
• Patient Age: 46 YR
• Patient Sex: Female