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

Model Number	8811313015
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	Peritonitis (2252)
Date of Event	07/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Occupation: health professional (hpro).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during use, the catheter had a leak at the exit site.The patient noticed that the dressing of her peritoneal dialysis catheter implanted was wet.The patient immediately drove to the clinic where a hole in the catheter tube was determined shortly at the exit.Due to its location, it was not technically possible to change the extension piece.On the same day, a laparotomic one-sided peritoneal dialysis catheter change took place.It was stated that the patient first noticed the catheter spontaneously twisted itself at the exit and a small groove on the catheter was noticed as well.It was also indicated that the catheter spontaneously twisted itself once a week.The patient has been performing the daily continuous ambulatory peritoneal dialysis(capd) treatments with 3 x 1500 ml 1,36 % glucose (physioneal 40) and 1 x 2000 ml extraneal.The patient has been rinsing the exit in the shower for 5 years and then dabbing it dry.The patient has also cleaned the exit 4 to 5 times a week with octenisept, aqueous wound and mucous membrane antiseptic.The patient was reported to have a complication of peritonitis and symptom of stomach pain.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: evaluation summary: post market vigilance (pmv) led a photographic evaluation of two photographs of a device.The first photo depicts the catheter cut.Two gloved hands are bending the device to show the cut.The second photo depicts the catheter cut.Two gloved hands are bending the device to show the cut.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.A review of the device history record could not be performed because the lot number was not provided.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: evaluation summary: post market vigilance (pmv) received one device.The visual inspection of the device revealed signs of use (remains of blood in the cuffs).The peritoneal dialysis(pd) catheter was received cut in two parts.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all medtronic quality release specifications at the time of manufacture.According to the event description, the perintoneal dialysis catheter was implanted and being able to be used for 5 years and 6 moths approximately.Therefore it can be concluded that it was manufactured according to the specifications and more likely damaged during use.The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident.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: 7718445
• Report Number: 3009211636-2018-00252
• Device Sequence Number: 13785457
• Product Code: FJS
• UDI-Device Identifier: 10884521004115
• UDI-Public: 10884521004115
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K890288
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/20/2018

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: 8811313015
• Device Catalogue Number: 8811313015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2018
• Initial Date Received by Manufacturer: 07/10/2018
• Supplement Date Received by Manufacturer: 08/08/2018; 09/28/2018; 10/26/2018
• Initial Report FDA Received Date: 07/25/2018
• Supplement Report FDA Received Date: 10/03/2018; 10/23/2018; 11/20/2018
• 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: Life Threatening
• Patient Age: 37 YR
• Patient Weight: 56