MAUDE Adverse Event Report: COVIDIEN LLC DIALYSIS UNKNOWN; CATHETER, PERITONEAL, LONG-TERM INDWELLING

Model Number DIALYSIS UNKNOWN

Device Problems Material Puncture/Hole (1504); Obstruction of Flow (2423)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/27/2023

Event Type  malfunction  

Event Description

According to the literature, a retrospective prospective study between september 2021 and february 2022 (which comprised records of patients who underwent tunneled dialysis catheter (tdc) placement between 2019 and 2020) was undertaken to assess the patency of tdcs and their results in patients in a tertiary care setting.Either a covadian plandrome [sic] in size 14.5 french and lengths 19 cm (centimiter), 23 cm, or 28 cm, or a competitor device were placed.One hundred thirty-four patients were included in the study.Complications included 16 cases of blockage (when flow rate was <(><<)>350 milliliters per minute even after flushing of the catheter with heparinized saline, secondary to a thrombus and/or fibrin sheath at the tip of the catheter) and 2 cases of physical damage (when a catheter was rendered inoperable by a tear or puncture).The authors did not provide information on which reported adverse events were related to the placement of a palindrome catheter or a competitor device.The catheter was flushed with heparinized the cathe ters were removed.There was no reported patient injury.

Manufacturer Narrative

D10 concomitant products: unk dy, dialysis unknown (lot#:unknown) unk dy, dialysis unknown (lot#:unknown).Misbah tahir, muhammad ali, danial khalid siddiqui, noureen durrani, jawaid iqbal, khalid mustafa.Tunneled dialysis catheter utilization and patency: a retrospectiveprospective study from a tertiary care hospital in karachi pakistan.Journal of the pakistan medical association vol.74, no.1.Doi: https://doi.Org/10.47391/jpma.8006.Pages 48-52 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 retrospective prospective study between (b)(6) 2021 and (b)(6) 2022 (which comprised records of patients who underwent tunneled dialysis catheter (tdc) placement between 2019 and 2020) was undertaken to assess the patency of tdcs and their results in patients in a tertiary care setting.Either a covadian plandrome [sic] in size 14.5 french and lengths 19 cm (centimeter), 23 cm, or 28 cm, or a competitor device were placed.(b)(4) patients were included in the study.Complications included (b)(4) of blockage (when flow rate was 350 milliliters per minute even after flushing of the catheter with heparinized saline, secondary to a thrombus and/or fibrin sheath at the tip of the catheter) and (b)(4) of physical damage (when a catheter was rendered inoperable by a tear or puncture).The authors did not provide information on which reported adverse events were related to the placement of a palindrome catheter or a competitor device.The catheter was flushed with heparinized the cathe ters were removed.They used tdc from (b)(4) companies in the past 10 years, and they did have records of the company's tdc used in patients, but unfortunately, for this study, they did not audit the adverse effects related to the company tdc used.There was no reported patient injury.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: DIALYSIS UNKNOWN
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): COVIDIEN LLC; 15 hampshire st; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN LLC; 15 hampshire st; mansfield MA 02048
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 18899807
• MDR Text Key: 337774569
• Report Number: 3009211636-2024-00079
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Reporter Country Code: PK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/12/2024
• 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
• Treatment: SEE H11.
• Patient Age: 65 YR
• Patient Sex: Male