MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature report with the FDA on 2019-05-22 for UNKNOWN PERITONEAL CATHETER manufactured by Covidien Mfg Solutions S.a..
[145738169]
Title: comparing the incidence of catheter-related complications with straight and coiled tenckhoff catheters in peritoneal dialysis patients? A single-center prospective randomized trial source: peritoneal dialysis international, volume 35, july 2015 (443? 449) article number: 4; date of publication: 13 october 2013. If information is provided in the future, a supplemental report will be issued. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[145738170]
According to literature source of study performed, straight and coiled catheters were used in 189 patients with end-stage renal disease. Of the 189 patients, 99 were randomized to the straight catheter group, whose members all received a 41-cm double-cuffed straight catheter with a 15. 5-cm intraperitoneal segment with a straight tip. The other 90 patients were randomized to the coiled catheter group, whose members all received a 62-cm double-cuffed catheter with a 17-cm intraperitoneal segment with a coiled tip. Catheter tip migration and omental wrapping were the most common causes of catheter dysfunction. Catheter dysfunction was the most common noninfectious complication in 23 of 189 patients (12. 2%). Catheter dysfunction was significantly more common in the group who used coiled catheters (17. 8% of patients) versus 7 of 99 patients who used straight catheters (7. 1%). Catheters were removed in 9 patients (4. 8%) because of peritonitis, leaks (1. 1%) and catheter-tip migration (0. 5%).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009211636-2019-00126 |
| MDR Report Key | 8630715 |
| Report Source | FOREIGN,LITERATURE |
| Date Received | 2019-05-22 |
| Date of Report | 2019-05-22 |
| Date Mfgr Received | 2018-10-26 |
| Date Added to Maude | 2019-05-22 |
| 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 | UNKNOWN PERITONEAL CATHETER |
| Generic Name | CATHETER, PERITONEAL, LONG-TERM INDWELLING |
| Product Code | FJS |
| Date Received | 2019-05-22 |
| Model Number | UNKNOWN PERITONEAL CATHETER |
| Catalog Number | UNKNOWN PERITONEAL CATHETER |
| 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. Other | 2019-05-22 |