COVIDIEN MFG SOLUTIONS S.A. DIALYSIS UNKNOWN; CATHETER, PERITONEAL, LONG-TERM INDWELLING
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Model Number DIALYSIS UNKNOWN |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problem
Injury (2348)
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Event Type
Injury
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Manufacturer Narrative
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Title: "percutaneous insertion of peritoneal dialysis catheters using ultrasound and fluoroscopic guidance: a single center experience and review of literature." source: journal of medical imaging and radiation oncology, volume 59, 2015 (662¿667), date of publication: 28 april 2015.If information is provided in the future, a supplemental report will be issued.(b)(4).
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Event Description
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According to the literature source of study performed various methods of peritoneal dialysis (pd) catheter insertion were available.The purpose of this study was to evaluate a percutaneous insertion technique using ultrasound (us) and fluoroscopy performed under conscious sedation and as day case procedure.Length of hospital stay, early complications and time to first use were also recorded.Early complications included bleeding (n = 3), catheter dysfunction (n = 6), exit site infection (n = 1) and exit site leakage (n = 1).All cases of catheter dysfunction and one case of bleeding required surgical revision.Median time of follow-up was 18 months (range 3¿35), and median time from insertion to first use was days 14 (1¿47).In all patients with catheter dysfunction, interventional radiology management was attempted but failed.Therefore, these patients required surgical repositioning.Spontaneous migration and reposition of pd catheters was observed in four patients.None of these migrations led to catheter dysfunction."percutaneous insertion of peritoneal dialysis catheters using ultrasound and fluoroscopic guidance: a single centre experience and review of literature." diederick w de boo, 2015 april 28.
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Manufacturer Narrative
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Correction: pma/510k medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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