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

Model Number PERITONEAL CATHETER

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

Patient Problem No Information (3190)

Event Date 03/01/2020

Event Type  malfunction  

Manufacturer Narrative

Title the engimatic oviduct : a challenging cause of pd catheter malfunction in young girl source kidney international reports.Conference: isn world congress, volume 5, 2020(s1¿s392) date of publication: 2020.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature source of study which reviewed challenging cause of catheter malfunction on a pediatric patient diagnosed as steroid resistant nephrotic syndrome and nephrotic sydrome type 2 (nphs2) at 18 months of age.A double cuff coiled tenchoff pd catheter was inserted using percutaneous selginger technique.It was stated that successful performance of peritoneal dialysis (pd) depends on a properly functioning pd catheter.Catheter malfunction remains a significant cause of technique failure, with rate of 15 % per year especially early in the course of therapy.Plane radiographs of the abdomen and pelvis after insertion confirmed that the tip of the catheter was located in the right place with initiation of automated peritoneal dialysis (apd) hourly exchanges of 4.25% dextrose daily achieved optimal solute clearance and ultrafiltration.Two weeks later, the patient presented with complaint of slow dialysate inflow and absent outflow.There was no abdominal pain, fever, loose bowel emotion, neither vaginal discharge upon examination.Revision of the pd catheter was done where old pd catheter was traced along its intra-abdominal course where catheter tip was found to be wrapped totally by omentum, fimbria and right fallopian tube and ovary.There were also nonspecific clinical signs of malfunction by ovarian fimbriae.Catheter occlusion by peritubular or ovarian tissue can be suspected in case of catheter malfunction, despite correct position in abdomen x-ray, in the presence of vaginal leakage of peritoneal fluid or blood, pain in the lower abdomen, or hemorrhagic peritoneal dialysis fluid.There was no reported 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 ; CR 20101
• Manufacturer (Section G): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CR 20101
• Manufacturer Contact: lisa hernandez ; 15 hampshire st.; mansfield, MA 02048 ; 2034925563
• MDR Report Key: 10050196
• MDR Text Key: 194055282
• Report Number: 3009211636-2020-00097
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Reporter Country Code: SA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2020
• 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
• Date Manufacturer Received: 04/27/2020
• 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: 5 YR