MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature report with the FDA on 2019-04-22 for ARGYLE 8811313010 manufactured by Covidien Mfg Solutions S.a..
[142734772]
(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).
Patient Sequence No: 1, Text Type: N, H10
[142734773]
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).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009211636-2019-00097 |
| MDR Report Key | 8537806 |
| Report Source | FOREIGN,LITERATURE |
| Date Received | 2019-04-22 |
| Date of Report | 2019-04-22 |
| Date Mfgr Received | 2018-10-26 |
| Date Added to Maude | 2019-04-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LISA HERNANDEZ |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 2034925563 |
| Manufacturer G1 | COVIDIEN MFG SOLUTIONS S.A. |
| Manufacturer Street | EDIFICIO B20, CALLE #2 |
| Manufacturer City | ALAJUELA 20101 |
| Manufacturer Postal Code | 20101 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARGYLE |
| Generic Name | CATHETER, PERITONEAL, LONG-TERM INDWELLING |
| Product Code | FJS |
| Date Received | 2019-04-22 |
| Model Number | 8811313010 |
| Catalog Number | 8811313010 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN MFG SOLUTIONS S.A. |
| Manufacturer Address | EDIFICIO B20, CALLE #2 ALAJUELA 20101 20101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-04-22 |