MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-05-09 for SPIDER FX manufactured by Covidien.
[144689501]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[144689502]
The physician was intending to use a hawkone to treat a calcified lesion with 99% stenosis in the distal/proximal right superficial femoral artery (sfa) and popliteal artery. A 7fr non medtronic sheath, a 300cm non medtronic guidewire and a 7mm embolic protection device were used in the procedure. The ifu was followed. It was reported that the wire wrapped around the cutter and the tip of the hawkone detached at the hinge pin. The broken hawkone and spider were removed from the patient and a balloon was used to successfully complete the procedure. No patient injury was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183870-2019-00245 |
| MDR Report Key | 8596051 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-05-09 |
| Date of Report | 2019-08-08 |
| Date of Event | 2019-04-01 |
| Date Mfgr Received | 2019-08-07 |
| Date Added to Maude | 2019-05-09 |
| 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 | TONI O'DOHERTY |
| Manufacturer Street | PARKMORE BUSINESS PARK WEST |
| Manufacturer City | GALWAY |
| Manufacturer Phone | 091708734 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | 4600 NATHAN LANE NORTH |
| Manufacturer City | PLYMOUTH MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55442 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPIDER FX |
| Generic Name | DEVICE, CORONARY SAPHENOUS VEIN BYPASS GRAFT, TEMPORARY, FOR EMBOLIZATION PROTEC |
| Product Code | NFA |
| Date Received | 2019-05-09 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 4600 NATHAN LANE NORTH PLYMOUTH MN 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-09 |