MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,03 report with the FDA on 2010-09-01 for SPECTRUM VENTRICULAR DRAINAGE CATHETER SET N-VVDC-01-ABRM manufactured by Cook, Inc..
[16738653]
Journal article received as follows: harrop, j. S. Sharan, a. D. Et al. (2010 july). Impact of a standardized protocol and antibiotic-impregnated catheters on ventriculostomy infection rates in cerebrovascular patients. Neurosurgery, 67:1, 187-191. Jefferson medical college submitted a study to the neurosurgery journal (volume 67/number 1/july 2010) titled "impact of a standardized protocol and antibiotic-impregnated catheters on ventriculostomy infection rates in cerebrovascular patients. " within that article, the physicians disclose their findings regarding the infection rates after implementing a standardized protocol for ventriculostomy catheter insertion with and without the use of antibiotic impregnated catheters. The physicians released the results during use of the cook incorporated spectrum ventricular drainage catheter set.
Patient Sequence No: 1, Text Type: D, B5
[17057394]
(b)(4) infection is addressed per the provided ifu. (b)(4) use of device is addressed per the provided ifu. Event is currently under investigation. As quoted from the journal entry, the physicians disclosed their methods: methods: between 2003 and 2008, 1961 ventriculostomies and infections were documented. A ventriculostomy infection was defined as 2 positive csf cultures from ventriculostomy catheters with a concurrent increase in cerebrospinal fluid white blood cell count. A baseline (preprotocol) infection rate was established (period 1). Infection rates were monitored after adoption of the standardized protocol (period 2), institution of antibiotic-impregnated catheter a (period 3), discontinuation of antibiotic-impregnated catheter a (period 4), and institution of antibiotic-impregnated catheter b (period 5). Results: the baseline infection rate (period 1) was 6/7% (22/327 devices). Standardized protocol (period 2) implementation did not change the infection rate (8. 2% 23/281 devices). Introduction of catheter a (period 3) reduced infections to 1. 0% (2/195, p =. 0005). Because of technical difficulties, this catheter was discontinued (period 4), resulting in an increase in infection rate (7. 6%; 12/157 devices). Catheter b (period 5) significantly decreased infections to 0. 9% (9 of 1001 devices, p =. 0001). The staphylococcus infection rate for periods 1, 2, and 4 was 6. 1% (47/765) compared with 0. 2% (1/577) during use of antibiotic-impregnated catheters (periods 3 and 5). Period 5, encompassing the fourth quarter of 2005 through the fourth quarter of 2008, began with the introduction of the ventricular catheter (b)(4) (catheter b). This device, coated with minocycline and rifampin, had a much lower rate of occlusion then the codman device; this is presumed to be a consequence of larger diameter fenestrations at the tip of the catheter. The final prospective observational time interval (period 5) consisted of implementation of antibiotic-coated ventricular catheter b. There was a concurrent reduction of the infection rate to 0. 9% (9/1001 infected), which was a significant decrease from baseline (period 1) (p=. 0001). Conclusion was the use of antibiotic-impregnated catheters resulted in a significant reduction of ventriculostomy infections and is recommended in the adult neurosurgical population. Cook catheters were involved in the period 5 (catheter b) in which 9 events occurred with infection noted. No further information is known.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1820334-2010-00429 |
| MDR Report Key | 1828065 |
| Report Source | 00,03 |
| Date Received | 2010-09-01 |
| Date of Report | 2010-08-03 |
| Report Date | 2010-08-03 |
| Date Mfgr Received | 2010-08-03 |
| Date Added to Maude | 2010-09-10 |
| 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 | RITA HARDEN, MANAGER |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPECTRUM VENTRICULAR DRAINAGE CATHETER SET |
| Generic Name | NHC CATHETER, VENTRICULAR (CONTAINING ANTIBIOTIC OR ANTIMICROBIAL AGENTS) |
| Product Code | NHC |
| Date Received | 2010-09-01 |
| Model Number | NA |
| Catalog Number | N-VVDC-01-ABRM |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK, INC. |
| Manufacturer Address | BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-09-01 |