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 2019-01-04 for SPIDER FX manufactured by Covidien.
[132037376]
The spider device was not returned for evaluation. A visual inspection of the returned hawkone 7f showed damage which indicated that the spider fx capture wire prolapsed. It was discovered while inspecting the distal assembly of the hawkone 7f, the proximal end of the rotating tip guidewire lumen showed yellow/green fragments which was consistent with the appearance of ptfe from a spider fx capture wire. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[132037377]
The physician was attempting to use a h1-lx with a 7mm spider fx and a non-medtronic 7f sheath to treat a calcified lesion in the superficial femoral artery (sfa) described as moderately tortuous and severely calcified. The 120mm lesion exhibited 85% stenosis in an artery diameter of 6mm. During preparation and while taking the device out of its package it was noted that the tip of the green delivery catheter was kinked. There was no issue with hawk lx out of its package. The vessel was pre-dilated. The guidewire was hydrated at preparation and advanced over a bifurcation. Minimum resistance was felt upon withdrawal causing tip damage and the guidewire lumen was torn from the distal tip. The spider and the hawk lx were removed in tandem. A new spider and a new hawk h1-m were used to complete the procedure. The vessel was post dilated and there was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183870-2019-00004 |
| MDR Report Key | 8216564 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-01-04 |
| Date of Report | 2019-01-04 |
| Date of Event | 2018-10-17 |
| Date Mfgr Received | 2018-12-13 |
| Date Added to Maude | 2019-01-04 |
| 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 | 2019-01-04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2019-01-04 |