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 2019-05-02 for SPIDER FX SPD2-US-060-320 manufactured by Covidien.
[143842634]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[143842635]
The physician was using a hawkone to treat a 50mm moderately calcified chronic total occlusion (cto) in the mid right superficial femoral artery (sfa) of diameter of 5-7mm. A non medtronic 6fr x 45cm sheath and a 6 x 320 spider embolic protection device was used in the procedure. The ifu was followed without issues. Severe tortuosity of the iliac arteries was reported and there were existing stents in both right and left common iliacs. The bifurcation was preserved and a sheath was placed up and over from the contra-lateral side. Severe resistance was encountered during withdrawal of the hawk and spider devices. It was reported that the guidewire prolapsed and locked up on the hawkone causing damage to the tip of the hawkone at or near the cutter window. The guidewire lumen was not torn from the distal tip but the nosecone detached at the hinge pin. An arterial cutdown was required on the right side to remove the spider and the hawkone including the detached tip. The patient was sedated and intubated for the procedure. The sheath was exchanged on the contra-lateral side and the physician crossed the previous lesion and completed balloon angioplasty. The patient encountered some difficulty with the sedation later that evening and required intubation but had stabilised the following morning.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183870-2019-00200 |
| MDR Report Key | 8573602 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-05-02 |
| Date of Report | 2019-06-24 |
| Date of Event | 2019-04-30 |
| Date Mfgr Received | 2019-06-14 |
| Device Manufacturer Date | 2019-03-29 |
| Date Added to Maude | 2019-05-02 |
| 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 | 2019-05-02 |
| Returned To Mfg | 2019-05-15 |
| Catalog Number | SPD2-US-060-320 |
| Lot Number | A806761 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 1. Required No Informationntervention | 2019-05-02 |