MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-17 for SSPIDERFX EMBOLIC PROTECTION DEVICE SPD2-US-060-190 manufactured by Medtronic Inc/ev3 Inc..
[131206045]
During an elective cardiac catheterization procedure, the filter basket of the sspider fx broke off. Retrieval attempts failed. Cardiothoracic intervention was required to retrieve the device. Name and strength: sspiderfx, 6. 0mmx190mm, spd2-us-060-190.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5082250 |
| MDR Report Key | 8176185 |
| Date Received | 2018-12-17 |
| Date of Report | 2018-11-28 |
| Date of Event | 2018-11-12 |
| Date Added to Maude | 2018-12-18 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SSPIDERFX EMBOLIC PROTECTION DEVICE |
| Generic Name | TEMPORARY CORONARY SAPHENOUS VEIN BYPASS GRAFT FOR EMBOLIC PROTECTION |
| Product Code | NFA |
| Date Received | 2018-12-17 |
| Catalog Number | SPD2-US-060-190 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC INC/EV3 INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other; 3. Required No Informationntervention | 2018-12-17 |