MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-06 for INTEGRA-HERMETIC LARGE STYLE VENTRICULAR CATHETER INS-4500 manufactured by Integra Neurosciences.
[28380802]
On (b)(6) 2015 the patient underwent a craniotomy for recurrent pituitary macroadenoma, when a ventricular catheter was placed into the right lateral ventricle, through a small perforation in the frontal bone at the level of the coronal suture behind the frontal craniotomy using image guidance. The end of the catheter was brought through a separate small incision 1 cm in length. The ventricular catheter was trimmed and a luer-lok was fixed to the end of the catheter and the luer-lock was sutured to the scalp. The luer-lock was then attached to a closed system for external drainage. On (b)(6) 2015, the ventricular catheter was found to be disconnected from the luer-lok, and was unable to be retrieved manually from the scalp incision. On (b)(6) 2014 the patient went back to the operating room for retrieval of the disconnected ventricular catheter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5056963 |
| MDR Report Key | 5149399 |
| Date Received | 2015-10-06 |
| Date of Report | 2015-10-06 |
| Date of Event | 2015-09-18 |
| Date Added to Maude | 2015-10-14 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | INTEGRA-HERMETIC LARGE STYLE VENTRICULAR CATHETER |
| Generic Name | VENTRICULAR CATHETER SET |
| Product Code | HCA |
| Date Received | 2015-10-06 |
| Catalog Number | INS-4500 |
| Lot Number | 1143590 |
| Device Expiration Date | 2019-10-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA NEUROSCIENCES |
| Manufacturer Address | PLAINSBORO NJ US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-10-06 |