MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. DIALYSIS UNKNOWN; CATHETER, PERITONEAL, LONG-TERM INDWELLING

Model Number DIALYSIS UNKNOWN

Device Problems Migration or Expulsion of Device (1395); Infusion or Flow Problem (2964)

Patient Problem No Information (3190)

Event Date 03/01/2015

Event Type  malfunction  

Manufacturer Narrative

Title: peritoneal dialysis catheter insertion by surgical minilaparotomy: outcome analysis between nephrologist and surgeon source: p.M.Dogra, a.K.Hooda, g.Shanmugraj, and s.Kumar date: indian j nephrol.2018 jul-aug; 28(4): 265¿272.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature source of study which compared outcomes of 105 catheters inserted by surgical minilaparotomy technique done by a general surgeon (identified as ¿group s¿ inserted 43 peritoneal dialysis catheters or pdcs ) and a nephrologist (identified as ¿group n¿ inserted 62 pdcs) performed between january 2012 and march 2015, 100% of patients in groups s and 59.7% in group n underwent two cuff straight pdc insertions while the rest of 40.3% of the group n had two cuff curl pdc insertions.Two patients in either group had catheter migrations in which both pdcs had to be removed in group n compared to a single one removed in group s.It was also mentioned that it had flow problems.There was no reported patient outcome.

Manufacturer Narrative

Additional information: e1 (prefix, facility name), e3, g4 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.

• Brand Name: DIALYSIS UNKNOWN
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• MDR Report Key: 9506001
• MDR Text Key: 196249339
• Report Number: 3009211636-2019-00280
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DIALYSIS UNKNOWN
• Device Catalogue Number: DIALYSIS UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1