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Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problems
Abscess (1690); Fever (1858); Obstruction/Occlusion (2422)
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Event Date 04/07/2017 |
Event Type
Injury
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Manufacturer Narrative
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B3: event date was approximated to 04/07/2017 based on the events occurring over a three-year period and the article received for publication date of (b)(6) /2020.D4, h4: upn and lot number are unknown; therefore, the manufacture date and expiration date are unknown.
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Event Description
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It was reported via journal article that there were 12 patients with complications related use of a 10 f external-internal flexima adpl drainage catheter.Percutaneous transhepatic cholangiographies (ptc) and 10 f external-internal (flexima, boston scientific) percutaneous biliary drainages (pbd) were performed in 44 patients with inoperable malignant obstructive jaundice who had been hospitalized in the radiology department of our hospital over a three years period.It is necessary to prevent inoperable patients from entering hepato-renal failure in order to prolong lifetime as much as possible.Pbd and stent applications significantly improves impaired liver function, allowing the patients general condition improvement.Low complication rates and quickly improving general condition of patients without need for another surgery gradually increase the value of this radiological intervention.Six patients (13.6%) underwent external biliary drainage (ebd), 27 patients (61.4%) underwent internal-external biliary drainage(i-ebd) and metallic stents were placed in 11 patients (25%) on average 6 days (1-34 days) after i-ebd.Few complications were encountered, including catheters of 2 patients were dislocated within the first day after the procedure and were corrected with a guide wire.Additional complications were observed in 10 patients (22.7%) during follow-up.Fever was observed in 6 patients (13.7%) the day after the procedure in the early period and resolved within 24 after the procedure in the early period and resolved within 24 hours following antibiotic treatment.It was observed that the hours following antibiotic treatment.It was observed that the liver enzymes of the patients did not increase compared to liver enzymes of the patients did not increase compared to the pre-procedure values and the image was not interpreted as cholangitis.Abscess occurred within the first week after as cholangitis.Abscess occurred within the first week after the procedure in 2 patients (4.5%) who also had an operation the procedure in 2 patients (4.5%) who also had an operation history, and it was recorded as a procedure complication.In the long term, obstruction developed in the stent of 2 patients (18.2%).While external drainage was provided again in one of the patients, the other died due to the deterioration of his general condition.Ilikan, gulsah & akmangit, ilkay.(2020).Percutaneous transhepatic cholangiography, percutaneous biliary drainage and metallic endoprotesis applications in malign biliary obstructions.Journal of contemporary medicine.11.97-103.10.16899/jcm.764141.
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Event Description
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It was reported via journal article that there were 12 patients with complications related use of a 10 f external-internal flexima adpl drainage catheter.Percutaneous transhepatic cholangiographies (ptc) and 10 f external-internal (flexima, boston scientific) percutaneous biliary drainages (pbd) were performed in 44 patients with inoperable malignant obstructive jaundice who had been hospitalized in the radiology department of our hospital over a three years period.It is necessary to prevent inoperable patients from entering hepato-renal failure in order to prolong lifetime as much as possible.Pbd and stent applications significantly improves impaired liver function, allowing the patients general condition improvement.Low complication rates and quickly improving general condition of patients without need for another surgery gradually increase the value of this radiological intervention.Six patients (13.6%) underwent external biliary drainage (ebd), 27 patients (61.4%) underwent internal-external biliary drainage(i-ebd) and metallic stents were placed in 11 patients (25%) on average 6 days (1-34 days) after i-ebd.Few complications were encountered, including catheters of 2 patients were dislocated within the first day after the procedure and were corrected with a guide wire.Additional complications were observed in 10 patients (22.7%) during follow-up.Fever was observed in 6 patients (13.7%) the day after the procedure in the early period and resolved within 24 after the procedure in the early period and resolved within 24 hours following antibiotic treatment.It was observed that the hours following antibiotic treatment.It was observed that the liver enzymes of the patients did not increase compared to liver enzymes of the patients did not increase compared to the pre-procedure values and the image was not interpreted as cholangitis.Abscess occurred within the first week after as cholangitis.Abscess occurred within the first week after the procedure in 2 patients (4.5%) who also had an operation the procedure in 2 patients (4.5%) who also had an operation history, and it was recorded as a procedure complication.In the long term, obstruction developed in the implanted non-boston scientific metallic stent of 2 patients (18.2%).While external drainage was provided again in one of the patients, the other died due to the deterioration of his general condition.Ilikan, gulsah & akmangit, lkay.(2020).Percutaneous transhepatic cholangiography, percutaneous biliary drainage and metallic endoprotesis applications in malign biliary obstructions.Journal of contemporary medicine.11.97-103.10.16899/jcm.764141.
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Manufacturer Narrative
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B3: event date was approximated to 04/07/2017 based on the events occurring over a three-year period and the article received for publication date of 04/07/2020.
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Search Alerts/Recalls
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