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

Model Number PERITONEAL CATHETER

Device Problems Leak/Splash (1354); Insufficient Flow or Under Infusion (2182); Migration (4003)

Patient Problem Hematoma (1884)

Event Date 01/08/2022

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: unk pd peritoneal catheter, lot # unknown title: changing the peritoneal dialysis access algorithm with a precise technique of percutaneous seldinger pd catheter placement source: the journal of vascular access 2022, vol.23(4) 615¿623 © the author(s) 2022 article reuse guidelines: sagepub.Com/journals-permissions doi: 10.1177/11297298221077607 journals.Sagepub.Com/home/jva 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.

Event Description

According to the literature, a prospective study between august 30, 2019 and september 30, 2021 analyzed the outcomes of 64 patients who underwent placement of a medtronic argyle curl cath pd (peritoneal dialysis) catheter with 16f introducer kit using the spd (seldinger pd) ¿low peritoneal puncture¿ technique.There were five bleeding complications which were unrelated to the device, 1 minor tunnel tract hematoma and 4 catheter exit site bleeds.The authors indicate that bleeding was procedure related and a change in practice/technique prevented subsequent bleeding in study patients.It was also stated that dialysate leak occurred in three patients; one resolved with resting the catheter for 14 days and the other two occurred in very morbid patients with severe ascites at the time of spd, due to hepatic failure in one and heart failure in the other.Additionally, there were a total of 38 patients (61%) who had a follow-up imaging.Of these, 10 had a single and 28 had multiple follow-up studies.Of the cohort with follow-up imaging, 17 catheters (45%) remained in their initial position, 14 catheters (37%) demonstrated a small change in position but remained in an adequate position and 7 catheters (18%) demonstrated a significant change in position into what was considered as an inadequate position.Of the 61 catheters placed, only 2 had to be redone because of poor function; both showed significant migration into an inadequate position.One was successfully replaced with a spd catheter that has functioned well.One was moved laparoscopically and stitched in place but failed to function: this patient had a very large fibroid filling the pelvis.There was no reported final patient outcome.

• Brand Name: PERITONEAL CATHETER
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CS 20101
• Manufacturer (Section G): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CS 20101
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 15528665
• MDR Text Key: 306600370
• Report Number: 3009211636-2022-00293
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PERITONEAL CATHETER
• Device Catalogue Number: PERITONEAL CATHETER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/19/2022
• Initial Date FDA Received: 10/03/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Male