MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-02 for ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM 641CF0721 manufactured by Medos International Sarl.
[76821646]
Krd/hcg. It is anticipated that the device will be returned for analysis; however, the device has not yet been received. Additional information will be submitted within 30 days of receipt.
Patient Sequence No: 1, Text Type: N, H10
[76821647]
As reported by a healthcare professional, during coil embolization of a basilar artery aneurysm, a g2tdl complex fill coil (641cf0721/ s12761) failed to detach with using cables with different lots and a detachment control box (dcb00000500/c20654). The coil was removed from the microcatheter without difficulty and the procedure was continued without consequence for the patient; however, the procedure was delayed and riskier due to the event and the procedure was delayed 20 minutes. A pre-deployment electrical check had been performed. Upon pressing the power button, all lights illuminated and the system ready light illuminated. During the detachment cycle, the detachment light illuminated and the audible signal beeped. All connections fit properly without need for excessive force. It was reported that product would be returned for analysis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2954740-2017-00115 |
| MDR Report Key | 6607575 |
| Date Received | 2017-06-02 |
| Date of Report | 2017-05-09 |
| Date of Event | 2017-05-05 |
| Date Mfgr Received | 2017-08-07 |
| Device Manufacturer Date | 2017-01-07 |
| Date Added to Maude | 2017-06-02 |
| 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 | KAREN ANIGBO |
| Manufacturer Street | 821 FOX LANE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 5088288374 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM |
| Generic Name | NEUROVASCULAR EMBOLIZATION DEVICE |
| Product Code | HCB |
| Date Received | 2017-06-02 |
| Returned To Mfg | 2017-06-30 |
| Model Number | NA |
| Catalog Number | 641CF0721 |
| Lot Number | S12761 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDOS INTERNATIONAL SARL |
| Manufacturer Address | CHEMIN-BLANC 38 LE LOCLE NEUCHATEL SZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-02 |