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

Model Number PERITONEAL CATHETER

Device Problem Break (1069)

Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930); Peritonitis (2252); Foreign Body In Patient (2687)

Event Date 04/15/2022

Event Type  Injury  

Event Description

According to the literature, a retrospective study from april 2015 to october 2019 compared the outcomes of patients with peritoneal dialysis catheter removal with either the pull technique or the open surgical technique.There were 80 participants who had all previously received a standard double cuffed straight tenckhoff pd catheter.It was also stated that 59 patients had peritonitis and 1 patient with liver disease developed incisional dehiscence.Complications necessitating pd catheter removal included peritonitis and exit-site infection.All patients with positive cultures received antibiotics and it was administered intravenously for 2¿3 weeks after catheter removal.The authors also discuss complications after pd catheter removal which included incisional dehiscence.The authors also report 5 abdominal dialysis catheter breakages when using the pull technique (occurred after they adopted an intermittent traction technique) where the breakage occurs primarily outside the superficial cuff or between the deep and superficial cuffs (there were 5 catheters ruptured in this study, and the nephrologists surgically removed the remaining catheter and cuffs.Therefore, it was still a worthwhile attempt for patients concerned about pain or those who cannot tolerate prolonged surgery.The remaining catheters and cuffs were surgically removed.).

Manufacturer Narrative

Title: pull technique versus open surgical removal of the catheter for peritoneal dialysis: a retrospective cohort study source: clinical and experimental nephrology (2022) 26:827¿834 published date: 15 april 2022 concomitant product/s: unk pd peritoneal catheter (lot number: unknown) 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: 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: 15609406
• MDR Text Key: 301815685
• Report Number: 3009211636-2022-00303
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2022
• Is this an Adverse Event Report?: Yes
• 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
• Date Manufacturer Received: 09/29/2022
• 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
• Treatment: UNK PD PERITONEAL CATHETER (LOT NUMBER: UNKNOWN)
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male