MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-06-11 for CATHETER manufactured by Integra Nero Sciences.
[1163699]
Twist drill hole was made in left frontal adjacent to mid-line. Ventriculostomy catheter was attempted to be placed; when that failed the apparatus was being removed and the catheter rim became dislodged. A portion of the catheter sheared off and remained within the brain parenchyma of right cerebral hemisphere. Dates of use: 2009. Diagnosis or reason for use: mid brain bleed with intraventrical extension. Event abated after use stopped or dose reduced: no.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5011552 |
| MDR Report Key | 1404398 |
| Date Received | 2009-06-11 |
| Date of Report | 2009-06-11 |
| Date of Event | 2009-01-26 |
| Date Added to Maude | 2009-06-24 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | CATHETER |
| Product Code | HCA |
| Date Received | 2009-06-11 |
| Lot Number | REF# 110-4HMT |
| ID Number | 132537 |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA NERO SCIENCES |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2009-06-11 |