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 manufactured by Covidien.
[129327551]
A turbohawk atherectomy device was returned with a broken wire included. No other ancillary devices were included. The returned wire had characteristics which match that of a spider fx capture wire. The total length of the wire was 304cm. At approximately 174cm from the distal tip, the snap location of between the gold colored portion of the wire and black portion were identified. A loop/bend to the capture wire was identified at approximately 43cm from the distal tip. The distal end of the identified capture wire was bent at an approximate 45-degree angle and the ptfe appeared worn/skived. A spider fx convertible capture wire is 320 cm total in length. The gold colored portion of the capture wire was 190cm. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[129327552]
Physician was attempting to use a turbohawk with a spider fx device to treat soft tissue lesion with cto (chronic total occlusion-100%) in the mid left superficial femoral artery. Lesion length and artery diameter were 200mm and 7mm respectively. Ifu was followed and the device was prepped without issue. It was reported that the nose cone broke off where the catheter meets nosecone. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183870-2018-00534 |
| MDR Report Key | 8109728 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-11-28 |
| Date of Report | 2018-11-28 |
| Date of Event | 2018-09-18 |
| 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 | 2018-10-25 |
| 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 | 2018-11-28 |