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

Model Number	8811313013
Health Effect - Clinical Codes	Abscess (1690); Bacterial Infection (1735); Cellulitis (1768); Purulent Discharge (1812); Foreign Body Reaction (1868); Unspecified Infection (1930); Staphylococcus Aureus (2058); Foreign Body In Patient (2687)
Date of Event	12/07/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, they had a peritoneal dialysis catheter implanted in their lower abdomen for the purpose of facilitating and augmenting natural renal function.After approximately 21 months of the catheter being implanted in the patient, they were advised that their natural renal function had recovered and that the catheter could be removed.The catheter was removed by the same physician who performed the implant procedure.For the proceeding years, the patient intermittently experienced discharge and leakage of blood and liquids from the area where the catheter was removed, with diagnoses of skin infections, cellulitis with micro abscess and slight growth of (b)(6) for which the patient was prescribed antibiotics and topical treatments.There was then a diagnosis of a resolving cutaneous abscess on the abdominal wall and the patient was referred to a general surgeon for removal options due to the inconvenience of having to wear a bandage at all times.During the excision surgery a foreign body was found in and removed from the site, and was later identified as part of the dialysis catheter which had been implanted previously.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: ARGYLE
• Common Device Name: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• MDR Report Key: 7767694
• Report Number: 3009211636-2018-00268
• Device Sequence Number: 13949538
• Product Code: FJS
• UDI-Device Identifier: 10884521004092
• UDI-Public: 10884521004092
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K890288
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2018

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
• Operator of Device: Health Professional
• Device Model Number: 8811313013
• Device Catalogue Number: 8811313013
• Device Lot Number: 932345
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/11/2018
• Supplement Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 08/09/2018
• Supplement Report FDA Received Date: 10/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR