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

Model Number PERITONEAL CATHETER

Device Problems Break (1069); Obstruction of Flow (2423); Infusion or Flow Problem (2964)

Patient Problem No Information (3190)

Event Date 12/20/2015

Event Type  malfunction  

Manufacturer Narrative

Title: 'tenckhoff tunneled peritoneal catheter placement in the palliative treatment of malignant ascites: technical results and overall clinical outcome.Source: radiology and oncology,' 2016; 50(2): 197-203.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature, source of study performed in 94 patients (27 men; 28.7% and 67 women; 71.3%) between march 2006 and january 2013 that analyzed the technical feasibility and safety of the insertion of a peritoneal tunnelled catheter.The overall clinical outcomes in this patient population were analysed and the authors evaluated the feasibility and safety of intraperitoneal chemotherapy delivery through the catheter in patients with widespread ovarian cancer and refractory ascites using catumaxomab.All patients were successfully inserted with tunneled peritoneal catheter; in 90 patients, catheter was tunneled subcutaneously into the right flank, in the remaining 4 patients the peritoneal access was made in the left para and infraumbilical region and the catheter was tunneled in the left flank.Minor complications were noted like ascitic fluid leakage around the entry point of the catheter in the right flank (n = 4; 4%), catheter occlusion (n = 2; 2%) and sleeve formation around the tip of the catheter resulting in insufficient drainage (n = 1; 1%).Management of these complications included extra skin sutures around the catheter entry point (n = 4), catheter removal (n = 1) or catheter flushing (n = 2).The use of this device to administer chemotherapy is not an approved indication and as such is considered off label use.

• 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 street; mansfield, MA 02048 ; 2034925563
• MDR Report Key: 10808589
• MDR Text Key: 215299646
• Report Number: 3009211636-2020-00277
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2020
• 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
• Date Manufacturer Received: 10/26/2020
• 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 Outcome(s): Required Intervention
• Patient Age: 60 YR