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C.R. BARD, INC. (BASD) -3006260740 POWERPORT CLEARVUE ISP IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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| Catalog Number 5608062 |
| Device Problems
Device Tipped Over (2589); Blocked Connection (2888); Migration (4003)
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| Patient Problems
Bacterial Infection (1735); Pain (1994); Seroma (2069); Thrombosis/Thrombus (4440)
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| Event Date 11/06/2023 |
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Event Type
Injury
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Event Description
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It was reported through litigation process that sometime post a port placement, the device allegedly migrated and the patient allegedly experienced thrombosis and seromas.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 not provided.Therefore, the investigation is inconclusive for the reported migration issue, as no objective evidence was provided for review.Furthermore, 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.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.
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Manufacturer Narrative
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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.(expiry date: 03/2025).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 the litigation process that approximately one month post a port placement, the port was unable to be accessed.It was further reported that the port was allegedly found to be flipped under x-ray examination and migrated.It was also reported that the that the port was allegedly clotted and patient allegedly experienced shoulder and neck pain.Furthermore, the patient allegedly experienced with thrombosis, seromas and bacterial infection wth culture positive for coagulase-negative staphylococci.Reportedly, the port and the catheter were removed and treated with antibiotics and a new port was implanted.However, the current status of the patient is unknown.
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Manufacturer Narrative
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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 device was not returned for evaluation.Medical records were provided.The medical record alleges that the patient underwent an access port insertion as the left subclavian level with the help of fluoroscopy, a guide wire was advanced into the superior vena cava, further catheter was cut to required size and flushed thoroughly with heparin solution.Then with the help of fluoroscopy an vascular dilator with the peel away sheath was advance and the catheter was placed to the port itself into the housing pocket, the catheter was advanced across the midline into the right subclavian vein.The catheter was detached from the port as the blood was unable to withdraw, hence the catheter length was shortened to several centimeters, then the catheter was heparin solution.Approximately after twenty five days later the patient was evaluated for left subclavian port and skin on the site was open and the doctor was called to close it and there was no sign of drainage and infection on the site.After two months later patient underwent port check for central line complications and study showed the port-a-cath at left subclavian level, and the proximal tube was looped and the tip of the catheter terminate at the left brachiocephalic vein, contrast was injected thorough the port-a-cath.However the small fibrin sheath/thrombus at the distal tip resulting in partial retrograde flow of contrast into the brachiocephalic vein.No evidence of occlusion.Then approximately after nine months later patient underwent new port placement in which the old port was removed by making horizontal incision, as catheter was suspected with fibrin sheath to remove the catheter and port.A new port and catheter was placed for the replacement of old port, with the help of fluoroscopic guidance catheter was placed into the superior vena cava and the old catheter was removed, with the placement of new vascular dilator and peel away sheath over the wire catheter was safely secured with the port.The newly placed catheter and port was flushed with heparin solution and blood was able to withdraw.The removed port was sent for pathology study.On the next day, the infected port had fat necrosis and foreign body reaction, the patient were presentable for evaluation of possible port infection and she receives 2 letters of lr infusion for adrenaline insufficiency by weekly as an outpatient and it was port was unable to access.On x-ray shows the port to be flip manipulation was attempted and fluid drainage was also attempted the patient node the area has been hot and frim, it was also reported that the patient had having chest pain to the upper left area, neck pain over the time frame.The patient has been removing the scab from the end of the scar and the drainage fluid from the site which would normally a clear red fluid drains from the side but it was changed to yellow cloudy fluid the patient had also had chills and sweats and pain at the site.Then the patient was localized the pain to the port side with aching in a left axilla and neck.Urine analysis indicating positive leukocytes come up positive wbc and positive for urine bacteria with negative nitrites.It was also concerned for a possible left vascular port infection hence iv cefepime started.Chest x-ray was performed for the history of sepsis and the study showed left subclavian infused airport catheter is unchanged positioning with the distal tape in the expected location of the mid svc your right sided picc is noted with the distal tip projecting over the right atrium.On the next day an ultrasound duplex of left upper extremity study was performed for the left arm pain to rule out for any deep vein thrombosis the study shows no evidence for deep vein thrombosis involving the left upper extremity.Then the patient was started on iv daptomycin and recommended two weeks from the two weeks from the port explanation date.Two days later patient underwent exploration of lift mediport for the dysfunction with the clot burden and possible infection come on you're full thickness came insertion was made and the subcutaneous tissue were dissected to reach the encapsulated port the capsule was entered carefully using the scissor and the serious fluid was encountered.The culture was obtain and 2 sutures were intact at one upper corner of the port and at the locking cap.These were cut away to completely loosen the port.A third ethibond suture was noted at the other upper aspect of the port that had become compromised and was not attached to surrounding tissue allowing the port to rotate.The port was removed from the pocket and the catheter was easily removed.The tip of the port was sent to microbiology for culture.Cultures from port grew coagulase negative staph.Two days later catheter tip culture final report showed coagulase negative staph not lugdunensis.Three days later a computer tomography of just with iv contrast study was performed for the history of infected port left upper chest wall pain and swelling the study showed defined hypotension focus within the left upper cell wall which represents the recently removed both side.Gram stain report shows many gram positive cocci many gram positive bacilli and few gram negative bacilli.A computer tomography of left shoulder study was performed for the infected port and the shoulder pain and vomit the study showed defined hypodense focus again noted within the left upper chest wall with the adjacent subcutaneous inflammatory standings.Again approximately 2 days later the patient underwent implanted port in the right internal jugular a needle was used to access the right subclavian vein it then the guide wire was inserted into the needle and the resisted was met fluoroscopy revealed that the wire was curling in the subclavian vein multiple atoms to thread the guidewire was unsuccessful due to this coiling.A, new subclavian stick was unable to resulting the same wire coiling and the wire was inserted through this vein into the svc without issue.A port packet was created and the catheter was tunneled from the packet to the neck insertion fluoroscopy was used to confirm the location of catheter and the catheter was cut and attached to the port which lock in place using a locking cap the port was aspirated and then flushed with the heparinized saline etches its tray was performed for the status post mediport placement the study showed no pneumothorax following the placement of right internal jugular infuse a port.As the submitted medical record confirms there no significant evidence for the alleged device malfunction like port flip, device migration and blocked connection the investigation was unconfirmed for all the alleged deficiency.Additionally, it can be confirmed that the patient experienced pain, bacterial infection, thrombosis and seromas.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: 03/2025), g3, h6 (method).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.
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Event Description
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It was reported through the litigation process that approximately one month post a port placement, the port was unable to be accessed.It was further reported that the port was allegedly found to be flipped under x-ray examination and migrated.It was also reported that the that the port was allegedly clotted and patient allegedly experienced shoulder and neck pain.Furthermore, the patient allegedly experienced with thrombosis, seromas and bacterial infection wth culture positive for coagulase-negative staphylococci.Reportedly, the port and the catheter were removed and treated with antibiotics and a new port was implanted.However, the current status of the patient is unknown.
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