MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2004-03-18 for HAMILTON VENTRICULAR DRAINAGE ANTIMICROBIAL CATHETER HVDC-110-33-ICRM manufactured by Cook, Inc..
[366863]
The pt presented with aneurysmal sah in 2003 (ct-1) and underwent coiling of a left pcomm aneuyrysm. A catheter was placed on for evidence of hydrocephalus. A scan in 10/2003 demonstrates the catheter in good position(ct-2). The catheter was removed the next day. A follow-up ct scan performed the following day reveals a focal area of high density adjacent to the right frontal horn that appears to be the distal tip of the catheter or a radio-opaque marker (ct-3). A repeat ct scan performed two days later demonstrates persistence of this area of high-signal intensity (ct-4). This was the first catheter placed in this pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2004-00163 |
| MDR Report Key | 516438 |
| Report Source | 05,08 |
| Date Received | 2004-03-18 |
| Date of Report | 2004-02-20 |
| Date of Event | 2003-09-26 |
| Date Facility Aware | 2004-02-20 |
| Report Date | 2004-02-20 |
| Date Mfgr Received | 2004-02-20 |
| Date Added to Maude | 2004-03-22 |
| 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 | RITA HARDEN |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HAMILTON VENTRICULAR DRAINAGE ANTIMICROBIAL CATHETER |
| Generic Name | VENTRICULAR CATHETER |
| Product Code | NHC |
| Date Received | 2004-03-18 |
| Model Number | NA |
| Catalog Number | HVDC-110-33-ICRM |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 505465 |
| Manufacturer | COOK, INC. |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US |
| Baseline Brand Name | HAMILTON VENTRICULAR DRAINAGE ANTIMICROBIAL CATHETER |
| Baseline Generic Name | VENTRICULAR CATHETER |
| Baseline Model No | NA |
| Baseline Catalog No | HVDC-110-33-ICRM |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-03-18 |