MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-08-24 for MICROPLEX HYPERSOFT HELICAL 100154HS-V-A-CN manufactured by Microvention, Inc..
[83632025]
The lot number was provided. A review of the approved device history records indicated the lot met all release criteria. A lot history trending review was performed and there were no similar complaints for this lot number. The device has not yet been returned for evaluation. The investigation is currently underway.
Patient Sequence No: 1, Text Type: N, H10
[83632026]
It was reported that an embolization coil did not advance in the middle of the microcatheter, then the coil unexpectedly detached in the microcatheter. Both segments of the coil were removed from the patient. There was no reported intervention or patient injury. The patient's status is reported to be fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2032493-2017-00210 |
| MDR Report Key | 6819648 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-08-24 |
| Date of Report | 2017-07-26 |
| Date of Event | 2017-06-17 |
| Date Mfgr Received | 2017-07-26 |
| Device Manufacturer Date | 2015-09-30 |
| Date Added to Maude | 2017-08-24 |
| 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 | MS. DEBBY CALLAHAN |
| Manufacturer Street | 35 ENTERPRISE DRIVE |
| Manufacturer City | ALISO VIEJO CA 92656 |
| Manufacturer Country | US |
| Manufacturer Postal | 92656 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MICROPLEX HYPERSOFT HELICAL |
| Generic Name | EMBOLIZATION COIL |
| Product Code | HGC |
| Date Received | 2017-08-24 |
| Model Number | 100154HS-V-A-CN |
| Lot Number | 150923E2 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICROVENTION, INC. |
| Manufacturer Address | 35 ENTERPRISE DRIVE ALISO VIEJO CA 92656 US 92656 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-08-24 |