MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-12-10 for SPIDER FX SPD2-060-320 manufactured by Covidien Irvine.
[129748533]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[129748534]
Physician attempted to use a turbohawk with a spider fx, 8fr sheath and 0. 014 guidewire for treatment of a severely calcified plaque lesion with 80-90% stenosis in the patients proximal mid and distal superficial femoral artery and popliteal artery. There were no abnormalities reported in relation to anatomy and moderate tortuosity was reported. Ifu was followed and devices were prepped without issue. The vessel was pre-dilated. After cutting was completed with the turbohawk, the physician attempted to withdraw both devices but resistance was encountered as the spider guidewire was entangled with the turbohawk cutter. Attempts were made for removal but both the spider filer and turbohawk nose cone detached in the vessel and could not be retrieved. The patient was sent for surgery to successfully remove the detached pieces.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183870-2018-00574 |
| MDR Report Key | 8145767 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-12-10 |
| Date of Report | 2018-12-10 |
| Date of Event | 2018-12-06 |
| Date Mfgr Received | 2018-12-06 |
| Device Manufacturer Date | 2018-02-21 |
| Date Added to Maude | 2018-12-10 |
| 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 IRVINE |
| Manufacturer Street | 9775 TOLEDO WAY |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92618 |
| 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 | 2018-12-10 |
| Returned To Mfg | 2019-04-02 |
| Catalog Number | SPD2-060-320 |
| Lot Number | A601719 |
| 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 IRVINE |
| Manufacturer Address | 9775 TOLEDO WAY IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-12-10 |