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 2018-11-28 for SPIDER FX SPD2-US-060-320 manufactured by Covidien.
[129340324]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[129340325]
The physician reported using a spider filter wire and a hawkone m directional atherectomy catheter to treat a plaque cto (chronic total occlusion-100%) with little calcification in the right proximal popliteal artery. A 6 fr non-mdt sheath was used. It was reported that coating from the spider wire was noted on the tip of the nose cone of the h1-m device. It was reported that it appeared that the coating from the spider wire was coming off due to several advances of the hawk on and off the spider wire. The physician clamped the spider wire with a hemostat to the drape at the area in which it appeared that the coating of the wire had come off. The procedure continued with this device without complication. No patient complications were reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183870-2018-00540 |
| MDR Report Key | 8109985 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-11-28 |
| Date of Report | 2018-11-28 |
| Date of Event | 2018-10-31 |
| Date Mfgr Received | 2018-10-31 |
| Device Manufacturer Date | 2018-10-03 |
| Date Added to Maude | 2018-11-28 |
| 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 | 2018-11-28 |
| Catalog Number | SPD2-US-060-320 |
| Lot Number | A717896 |
| 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 | 2018-11-28 |