MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,literatur report with the FDA on 2019-01-08 for HERMETIC LARGE STYLE VENTRICULAR CATHETER SET INS4500 manufactured by Integra Neurosciences Pr.
[132497633]
The reported device was not returned for evaluation. Based on the absence of lot and catalog number used in the retrospective study published on 2013, it is not possible to perform the dhr review and neither to identify the manufacturing time frame for the histories review. The reported condition is unconfirmed. The evaluation of the complaint unit is required to determine a potential root cause of the reported condition. The root cause is undetermined. Doi: 10. 1227/neu. 0b013e318279e783. Linked to mfg report numbers: 2648988-2018-00083, 2648988-2018-00084, 2648988-2018-00085, 2648988-2018-00086, 2648988-2018-00087, 2648988-2018-00089, 2648988-2018-00090.
Patient Sequence No: 1, Text Type: N, H10
[132497634]
This is 6 out of 8 reports. Operative neurosurgery (2013) published "iatrogenic vascular complications associated with external ventricular drain placement: a report of 8 cases and review of the literature" in which described 9 cases of evd-related vascular trauma: arteriovenous fistulas and 2 traumatic aneurysms. This study includes patients who were treated in the neuro critical care unit at a university affiliated level i trauma center and children? S hospital during a 3-year period. Patients included in this study had placement of an evd and an angiographically confirmed vascular lesion associated with the evd. During a 3 year period, 299 evds were placed. An integra large-style ventricular catheter (3mm outer diameter) was passed through the craniostomy into the frontal horn of the lateral ventricle. The trajectory of the catheter in the coronal plane was the medial canthus of the ipsilateral eye and the external auditory canal in the sagittal plane. Catheters were not inserted deeper than 7 cm at the bone edge. Once clear cerebrospinal fluid was visualized, the metal stylet was removed and the catheters were tunneled subcutaneously approximately 2 to 3 cm away form the incision. The incision was closed with nylon suture and the ventricular catheter was connected to the drainage system in a sterile manner ad secured to the patient. A head ct was performed after the procedure to verify catheter position. Eight patients (2. 75%), 3 male and 5 female (mean age, 48 +/- 20 years), developed vascular lesions associated with evds. Six patients developed arteriovenous fistulas and 2 patients developed a traumatic aneurysm. Patient 6: a (b)(6) female had an admitting diagnosis of subarachnoid hemorrhage. The patient developed a dural arteriovenous fistula (avf). The arterial feeder of the superficial draining fistula arose from the right middle meningeal artery (mma). The fistula resolved spontaneously after evd removal. Conclusion: the data suggest that iatrogenic vascular trauma associated with evd insertions (2. 75%) may be more common than is currently appreciated. Endovascular treatment is effective and may be necessary when these lesions do not resolve spontaneously.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2648988-2018-00088 |
| MDR Report Key | 8228952 |
| Report Source | HEALTH PROFESSIONAL,LITERATUR |
| Date Received | 2019-01-08 |
| Date of Report | 2018-12-14 |
| Date Mfgr Received | 2018-12-14 |
| Date Added to Maude | 2019-01-08 |
| 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 | USER KIMBERLY SHELLY |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA NEUROSCIENCES PR |
| Manufacturer Street | ROAD 402 NORTH, KM 1.2 |
| Manufacturer City | ANASCO PR 00610 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00610 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HERMETIC LARGE STYLE VENTRICULAR CATHETER SET |
| Generic Name | N/A |
| Product Code | HCD |
| Date Received | 2019-01-08 |
| Catalog Number | INS4500 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA NEUROSCIENCES PR |
| Manufacturer Address | ROAD 402 NORTH, KM 1.2 ROAD 402 NORTH, KM 1.2 ANASCO PR 00610 US 00610 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-08 |