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

Model Number PERITONEAL CATHETER

Device Problem Obstruction of Flow (2423)

Patient Problems Adhesion(s) (1695); Nausea (1970); Obstruction/Occlusion (2422); Unintended Radiation Exposure (4565); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/05/2021

Event Type  Injury  

Manufacturer Narrative

Literature: title: small bowel obstruction with a transition point in a patient on peritoneal dialysis source: case rep nephrol dial 2022;12:6¿10 doi: 10.1159/000521350.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 patient was admitted for recurrent syncopal episodes and altered mental status.One month prior to patient admission, a double cuffed peritoneal dialysis (pd) catheter was placed laparoscopically without an omentectomy.There were no complications during the peritoneal dialysis placement.During the 2 weeks prior to admission, the patient underwent peritoneal dialysis (pd) training 5 times weekly.On post-operative day 6, the patient started to have incomplete drainage of the peritoneal dialysis (pd) solution.On day 7, an abdominal ct scan without contrast was ordered.This scan showed mildly dilated small bowel loops in the right lower quadrant without features of small bowel obstruction (sbo).Despite adding heparin to the peritoneal dialysis (pd) solutions and changing the treatment from continuous cycling peritoneal dialysis (pd) to continuous ambulatory peritoneal dialysis (pd) (2,000 ml, 1.5% dextrose, 2.5 meq calcium solution every 6 h), the patient continued to have incomplete drainage.On day 10, the patient started having nausea without vomiting or abdominal pain.On day 11, peritoneal dialysis was stopped.On day 12, a second abdominal ct scan showed dilated, stacked loops of proximal small bowel adjacent to the peritoneal dialysis (pd) catheter, indicating small bowel obstruction (sbo) with a transition point near the peritoneal dialysis (pd) catheter, which represent a continuation of the lesions identified by the first ct scan.The patient was transitioned to hemodialysis and treated via a nasogastric tube with intermittent suctioning.The patient then underwent a diagnostic laparoscopy that revealed omental adhesions around the peritoneal dialysis (pd) catheter near the obstruction area, but no adhesion of the intestine.The adhesions were dissected by laparoscopy, and the peritoneal dialysis (pd) catheter was removed.The patient¿s condition improved after the surgery, and was discharged to a rehabilitation facility on hemodialysis.

• 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: clay chandler ; 5920 longbow drive; boulder, CO 80301 ; 3035306409
• MDR Report Key: 14836458
• MDR Text Key: 295047463
• Report Number: 3009211636-2022-00159
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/16/2022
• Initial Date FDA Received: 06/27/2022
• 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 Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female