MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-30 for TARGET XL 360 STANDARD 16MM X 50CM M0036101650 manufactured by Stryker Neurovascular Cork.
[186205296]
The automated manufacturing execution system (mes) has controls in the manufacturing process to ensure the product met specifications upon release. The device history record review confirms that the device met all material, assembly and performance specifications. Visual inspection performed on the returned device revealed that the main coil was severely stretched and detached from the delivery wire and the coil suture was found damaged. In addition, the coil delivery wire was found to be kinked/bent. Functional testing was not required as the reported defects were confirmed. Based on the information provided in the complaint and the device analysis, it is most likely that the coil encountered resistance from procedural factors when it was retracted into the microcatheter which then caused it to further stretch, resulting in suture damage and mechanically detachment during manipulation. Therefore, a probable cause of procedural factors will be assigned to the as reported events. It can be presumed that the delivery wire was kinked during the procedure as excessive force may have been applied at the proximal end of the device during retraction. Therefore, a probable cause of handling damage will be assigned. The reported event is covered in the device directions for use (dfu). Also, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event. Based on the investigation results and available information an assignable cause of procedural factors will be assigned to the alleged complaint.
Patient Sequence No: 1, Text Type: N, H10
[186205297]
It was reported that during the procedure, the subject coil stretched when the physician tried to retrieve the coil out of the aneurysm. While removing, the subject coil detached inside the microcatheter. The devices were replaced and the procedure was completed successfully. There were no reported clinical consequences to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008881809-2020-00078 |
| MDR Report Key | 9897338 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-01-20 |
| Date Mfgr Received | 2020-03-03 |
| Device Manufacturer Date | 2019-07-18 |
| Date Added to Maude | 2020-03-30 |
| 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 STANDARD 16MM X 50CM |
| Generic Name | DEVICE, NEUROVASCULAR EMBOLIZATION |
| Product Code | HCG |
| Date Received | 2020-03-30 |
| Returned To Mfg | 2020-02-28 |
| Model Number | M0036101650 |
| Catalog Number | M0036101650 |
| Lot Number | 21593980 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-03-30 |