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

Model Number 8811313010

Device Problem Product Quality Problem (1506)

Patient Problems Unspecified Infection (1930); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Title: "a novel adaptation of laparoscopic tenckhoff catheter insertion technique to enhance catheter stability and function in automated peritoneal dialysis." source: langenbecks arch surg, volume 399, 2014 (525¿532).Date of publication: 8 december 2013.If information is provided in the future, a supplemental report will be issued.(b)(4).

Event Description

According to the literature source of study performed between march 2009 and november 2011, 54 patients underwent pd catheter insertion.The technique used combines and optimizes previously described laparoscopic catheter implantation techniques, allowing increased catheter stability resulting in an undisturbed catheter function suitable for apd (automated peritoneal dialysis).After catheter insertion, pd (peritoneal dialysis) was possible in 53 of 54 patients (98.1 %).Applying stronger functional criteria, in 51 of 54 patients (94.4 %), catheter function would allow an undisturbed catheter function suitable for apd.In three cases where catheter function was considered insufficient for apd, catheter replacement was performed in one patient, while catheter function was adequate for capd in the remaining two patients.Irrespective of primary function, catheter removal was undertaken in four patients during the study period, due to abdominal trauma (one), major abdominal surgery (one) and infection (two).

• Brand Name: ARGYLE
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• Manufacturer (Section G): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• Manufacturer Contact: lisa hernandez ; 15 hampshire street; mansfield, MA 02048 ; 2034925563
• MDR Report Key: 8537806
• MDR Text Key: 142734772
• Report Number: 3009211636-2019-00097
• Device Sequence Number: 1
• Product Code: FJS
• UDI-Device Identifier: 10884521004085
• UDI-Public: 10884521004085
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K890288
• 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: 04/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8811313010
• Device Catalogue Number: 8811313010
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/26/2018
• 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