MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-17 for ONYX ANEURYSM UNK-NV-ONYX AN manufactured by Micro Therapeutics, Inc. D/b/a Ev3 Neurovascular.
[124071108]
The device involved in the event will not been returned for evaluation as it was consumed in the event; therefore, the event cause could not be determined. For apollo microcatheter, reference mdr# 2029214-2018-00858. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[124071109]
Medtronic received information that the medtronic flow directed microcatheter ruptured in the middle of the microcatheter (but remained intact) while the medtronic liquid embolic was being injected through it at a rate of 0. 05 ml/min continuously without pause. There was no reflux. A minor amount of medtronic liquid embolic leaked out and remained in the patient and was not removed as it moved to the distal end. Another apollo microcatheter was used to complete the procedure. No other complications were reported with the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2029214-2018-00859 |
| MDR Report Key | 7976339 |
| Date Received | 2018-10-17 |
| Date of Report | 2018-10-17 |
| Date of Event | 2018-09-12 |
| Date Mfgr Received | 2018-09-12 |
| Date Added to Maude | 2018-10-17 |
| 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 | DIR. TRICHA MILES |
| Manufacturer Street | 9775 TOLEDO WAY |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9492979558 |
| Manufacturer G1 | MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR |
| Manufacturer Street | 9775 TOLEDO WAY |
| Manufacturer City | IRVINE CA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ONYX ANEURYSM |
| Generic Name | POLYMERIZING, NEUROVASCULAR EMBOLIZATION MATERIAL |
| Product Code | OBA |
| Date Received | 2018-10-17 |
| Catalog Number | UNK-NV-ONYX AN |
| Lot Number | NOT-REP |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR |
| Manufacturer Address | 9775 TOLEDO WAY IRVINE CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2018-10-17 |