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 2018-11-28 for SPIDER FX manufactured by Covidien.
[128562420]
Evaluation summary: a portion of the spider fx was included with the hawkone distal assembly loaded over the capture wire with the filter assembly intact. Apart from the hawkone device involved in this event, no other ancillary devices were included. The distal segment of the hawkone showed the capture wire of the spider fx loaded over the rotating tip of the distal assembly. The filter of the spider fx was opened and located at the distal tip of the distal assembly. Approximately 12 cm of the spider fx capture wire/filter assembly were returned. The capture wire showed a bend at approximately 10cm from the distal tip. The fracture face of the proximal end of the capture wire showed worn away ptfe at the proximal end. No damage to the filter or coiled tip were noted. Traces of biological material were noted within the filter. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[128562421]
The physician intended to use the hawkone with a spider fx device for treatment of the patients common femoral artery. It was reported that resistance was experienced while removing the device. The hawkone broke in the 6f introducer sheath near the end of the procedure and half of the nosecome was stuck in the introducer sheath which was in still in the patient. The device was removed safely and all components were removed from the patient during surgery. It was possible to turn off the thumbswitch. No patient injury was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183870-2018-00539 |
| MDR Report Key | 8109795 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-11-28 |
| Date of Report | 2018-11-28 |
| Date of Event | 2018-09-21 |
| Date Mfgr Received | 2018-10-31 |
| 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 |
| Returned To Mfg | 2018-10-29 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2018-11-28 |