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 2018-11-26 for SPIDER FX SPD2-US-030-320 manufactured by Covidien.
[128296371]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[128296372]
Physician used a 3mm spider fx with a non-medtronic (cook ansel) 6fr sheath and non-medtronic (abbott command). 014 guidewire during treatment of a 20mm, 70% calcified lesion in the patients proximal left posterior tibial artery and tibial/popliteal trunk. Vessel diameter reported as 3mm. Slight tortuosity and moderate calcification are reported. Ifu was followed and the device was prepped without issue. It is reported the rear portion of spider fx catheter broke into 2 segments but remained on the filter wire. The broken segments were successfully retrieved into the sheath and removed over the non-medtronic wire. 014 wire. It is reported that difficulty had been experienced when getting the wire to exit the proximal port. It is believed the catheter may have been kinked trying to open the port, so the wire could exit more easily. The physician then placed a new 6fr 55cm sheath and rewired the lesion with a new non-medtronic wire. The lesion was ballooned. The physician was satisfied with the result. Additional angiograms were carried out to ensure no damage to patient vasculature. Angiogram confirmed good flow distally to the foot.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183870-2018-00532 |
| MDR Report Key | 8102031 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-11-26 |
| Date of Report | 2019-02-04 |
| Date of Event | 2018-11-14 |
| Date Mfgr Received | 2019-01-18 |
| Device Manufacturer Date | 2018-07-02 |
| Date Added to Maude | 2018-11-26 |
| 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 | 2018-11-26 |
| Returned To Mfg | 2019-01-02 |
| Catalog Number | SPD2-US-030-320 |
| Lot Number | A669767 |
| 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 | 2018-11-26 |