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 XL 360 SOFT 5MM X 15CM M0036125150 manufactured by Stryker Neurovascular Cork.
[186204041]
Device not returned for analysis.
Patient Sequence No: 1, Text Type: N, H10
[186204042]
It was reported that during coil embolization of acom unruptured aneurysm, the subject coil stretched when attempted to re-position. A gooseneck snare was used to retrieve the coil. The subject device was replaced and the procedure was completed successfully. There were no clinical consequences to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008881809-2020-00075 |
| MDR Report Key | 9868281 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-23 |
| Date of Event | 2020-02-26 |
| Date Mfgr Received | 2020-02-26 |
| 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 XL 360 SOFT 5MM X 15CM |
| Generic Name | DEVICE, NEUROVASCULAR EMBOLIZATION |
| Product Code | HCG |
| Date Received | 2020-03-23 |
| Model Number | M0036125150 |
| Catalog Number | M0036125150 |
| Lot Number | 21017474 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| 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 | 1. Required No Informationntervention | 2020-03-23 |