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

Model Number	8888411405
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led evaluation of one video of the device.The visual inspection video depicts the catheter being used during a surgical procedure.The surgeon is picking at the cuff.A review of the device history record could not be performed because the lot number was not provided.However, records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Our investigation was unable to determine a root cause or establish a relationship between the device and the reported condition.No enhancements or improvements were generated for the reported condition.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during use, it was found that the cuff appeared to be out f the implant site.It was also found that the cuff slides (velvet an glue detached) and the glue was less compared to before.It was also stated that implant previously had an infection and there were concern there was damage to the tubing.There was no reported patient injury.

• 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: 8304902
• Report Number: 3009211636-2019-00022
• Device Sequence Number: 10778669
• Product Code: FJS
• UDI-Device Identifier: 10884521054974
• UDI-Public: 10884521054974
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K862046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8888411405
• Device Catalogue Number: 8888411405
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2019
• Initial Report FDA Received Date: 02/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1