MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-23 for TARGET HELICAL ULTRA 2MM X 8CM M0035432080 manufactured by Stryker Neurovascular Cork.
[184509303]
The device is not available to the manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[184509304]
It was reported that after the coil (subject device ) was placed inside the aneurysm, it was attempted to be detached 5 times without success. During retraction of the coil delivery wire, the subject coil prematurely detached, placed inside the parent artery, and was managed to be placed back at the target site by pushing with the microcatheter and guidewire. The procedure was completed successfully without clinical consequences to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008881809-2020-00068 |
| MDR Report Key | 9865530 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-23 |
| Date of Event | 2020-03-03 |
| Date Mfgr Received | 2020-03-03 |
| Date Added to Maude | 2020-03-23 |
| 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 | MR. TARA LOPEZ |
| Manufacturer Street | 47900 BAYSIDE PARKWAY |
| Manufacturer City | FREMONT CA 94538 |
| Manufacturer Country | US |
| Manufacturer Postal | 94538 |
| Manufacturer Phone | 5104132500 |
| Manufacturer G1 | STRYKER NEUROVASCULAR CORK |
| Manufacturer Street | IDA INDUSTRIAL ESTATE MODEL FARM ROAD |
| Manufacturer City | CORK NA |
| Manufacturer Country | IE |
| Manufacturer Postal Code | NA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TARGET HELICAL ULTRA 2MM X 8CM |
| Generic Name | DEVICE, NEUROVASCULAR EMBOLIZATION |
| Product Code | HCG |
| Date Received | 2020-03-23 |
| Model Number | M0035432080 |
| Catalog Number | M0035432080 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER NEUROVASCULAR CORK |
| Manufacturer Address | IDA INDUSTRIAL ESTATE MODEL FARM ROAD CORK NA IE NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-23 |