C.R. BARD, INC. (BASD) -3006260740 POWERPORT M.R.I. IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Catalog Number 1808001 |
Device Problems
Fracture (1260); Expulsion (2933)
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Patient Problems
Chest Pain (1776); Unspecified Infection (1930)
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Event Date 01/18/2012 |
Event Type
Injury
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Manufacturer Narrative
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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.
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Event Description
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It was reported through litigation process that sometime post a port placement, the port allegedly fractured, and the port eroded.It was further reported that patient allegedly developed infection and alleged having chest pain.However, the current status of the patient is unknown.
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Event Description
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It was reported through litigation process that one year, two months and seven days post a port placement via the right subclavian vein, the port was allegedly fractured and eroded.It was further reported that the patient allegedly experienced chest pain and developed infection, bacteremia and was also informed to possibly have endocarditis.Reportedly, the port was removed and replaced.However, the current status of the patient is unknown.
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Manufacturer Narrative
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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 one year and seven months post second port placement, the patient diagnosed with bacteremia and possible endocarditis.Powerport removal was planned.Right chest was prepped and draped.Incision was made and port dissected free from tissue and removed with catheter intact.Around two months and three days later, placement of right subclavian bard power port was completed successfully.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 and completed successfully.Approximately two years and six months post fourth port placement, x ray port revealed that the port was malpositioned.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.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.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 inconclusive for the reported fracture and expulsion 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: g2, g3, h6 (patient, method) h11: b3, b5 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.
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Manufacturer Narrative
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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.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.The patient was taken in stable condition.Therefore, the investigation is inconclusive for the reported fracture and expulsion as no objective evidence was provided for review.Additionally, it can be confirmed that the patient experienced port erosion, chest pain, bacteremia.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.(expiry date: 03/2012) 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.
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Event Description
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It was reported through litigation process that one year, two months and two days post a port placement via the right subclavian vein, the port was allegedly fractured and eroded.It was further reported that the patient allegedly experienced chest pain and developed bacteremia and was also informed to possibly have endocarditis.Reportedly, the port was removed and replaced.However, the current status of the patient is unknown.
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