MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2007-03-23 for VENTRICLEAR VENTRICULAR DRAINAGE CATHETER N-VVDC-01-ABRM manufactured by Cook, Inc..
[591590]
In 2007, the pt was newly diagnosed with arterial fibrillation, placed on anticoagulants and became acutely confused. The pt was brought to another hosp and ct demonstrated intracranial hemorrage. The pt was then transffered to this hosp. Craniotomy with ventricular drain placed in left lateral ventricle. Two weeks later, during removal of the drain, the drain fractured and partially remained in the cranium per ct. Ten days later, removal of the drain followed by insertion of a left frontal subdural peritoneal shunt took place.
Patient Sequence No: 1, Text Type: D, B5
[7943299]
Evaluation: no product or lot number was provided by the customer. However, based on the information provided, it is feasible to say that the catheter encountered excessive force during removal. A review of our procedures found this device is visually inspected 100% to assure that it is free of damage, dirt and foreign debris prior to further processing.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1820334-2007-00062 |
| MDR Report Key | 831227 |
| Report Source | 05,07 |
| Date Received | 2007-03-23 |
| Date of Event | 2007-01-25 |
| Report Date | 2007-02-22 |
| Date Mfgr Received | 2007-02-22 |
| Date Added to Maude | 2007-03-28 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | VENTRICLEAR VENTRICULAR DRAINAGE CATHETER |
| Generic Name | NHC VENTRICULAR CATHETER |
| Product Code | NHC |
| Date Received | 2007-03-23 |
| Model Number | NA |
| Catalog Number | N-VVDC-01-ABRM |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNK |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 818563 |
| Manufacturer | COOK, INC. |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US |
| Baseline Brand Name | VENTRICLEAR VENTRICULAR DRAINAGE CATHETER |
| Baseline Generic Name | NHC VENTRICULAR CATHETER |
| Baseline Model No | NA |
| Baseline Catalog No | N-VVDC-01-ABRM |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-03-23 |