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

Model Number PERITONEAL CATHETER

Device Problems Break (1069); Migration or Expulsion of Device (1395)

Patient Problem Peritonitis (2252)

Event Date 05/16/2021

Event Type  Death  

Manufacturer Narrative

Title: outcomes after acute peritoneal dialysis for critical cardiorenal syndrome type 1 source: cardiorenal med 2021;11:184¿192.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature source of study, the aim of the study was to demonstrate the outcomes of peritoneal dialysis (pd) in critically ill cardiorenal syndrome type 1 (crs1).A cohort of 147 patients with crs1 who received pd from 2011 to 2019 in a referral hospital in (b)(6) was analyzed.Flexible-coiled pd insertions (quinton percutaneous insertion kit) were performed by nephrologists using a percutaneous bedside technique without imaging guidance.The primary outcome was 30-day in-hospital mortality.The overall 30-day in-hospital mortality rate was 73.5% (108 out of 147).There were 108 deaths in total, 5.6% of the dead patients had pd peritonitis, 2.8% had malposition needed revision, 6.4% had pd leakage and 4.6% had pd technical failure - switched to ihd/crrt (intermittent hemodialysis/continuous renal replacement therapy).

• 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: avi kluger ; 5920 longbow drive; boulder, CO 80301 ; 3035306582
• MDR Report Key: 12862207
• MDR Text Key: 281155340
• Report Number: 3009211636-2021-00331
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Reporter Country Code: TH
• 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: 11/23/2021

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
• Initial Date Manufacturer Received: 11/04/2021
• Initial Date FDA Received: 11/23/2021
• 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): Death; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 57 KG