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

Model Number	8817278006
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Unspecified Infection (1930); Foreign Body In Patient (2687); Unintended Radiation Exposure (4565)
Date of Event	08/10/2020
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, the cap for the tunneling stylet of the peritoneal dialysis catheter fell off into the patient during surgery.It was also stated that it was not discovered for few days and they had to go back into the patient to get it.There was no reported patient outcome.
Additional Manufacturer Narrative
Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the cap for the tunneling stylet of the peritoneal dialysis catheter fell off during surgery and remained in the patient for 17 days.It was also stated that it was not discovered for few days and they had to go back into the patient to get it.It was also mentioned that there was no damage/defect to the catheter itself, the cap of the tunneling stylet was not removed prior to start of the insertion procedure and the cap did not show up on the x-ray.It was also mentioned that the cap was retrieved through open surgical site.The patient developed surgical site infection and was readmitted for 5 (five) days.There was no other product being utilized with the device, chg (chlorhexidine gluconate) was used to treat the insertion site prior to product placement, the catheter was removed and 2 grams of ancef antibiotics was given to the patient through iv (intravenous).

• 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 ; CS 20101
• MDR Report Key: 11138617
• Report Number: 3009211636-2021-00010
• Device Sequence Number: 2350150
• Product Code: FJS
• UDI-Device Identifier: 10884521004252
• UDI-Public: 10884521004252
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K180485
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2021

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
• Operator of Device: Health Professional
• Device Model Number: 8817278006
• Device Catalogue Number: 8817278006
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/14/2020
• Supplement Date Received by Manufacturer: 01/12/2021
• Initial Report FDA Received Date: 01/08/2021
• Supplement Report FDA Received Date: 02/03/2021
• 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: Hospitalization; Required Intervention
• Patient Age: 50 YR
• Patient Weight: 111