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 2019-04-17 for SPIDER FX SPD2-US-060-320 manufactured by Covidien.
[142506710]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[142506711]
The physician was intending to use a 6mm spider during treatment. A 6fr sheath was used in the procedure and the ifu was followed. It was reported that the catheter broke in half and another product was used to complete the procedure. No patient injury was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183870-2019-00176 |
| MDR Report Key | 8522516 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-04-17 |
| Date of Report | 2019-07-09 |
| Date of Event | 2019-04-12 |
| Date Mfgr Received | 2019-07-08 |
| Device Manufacturer Date | 2019-03-06 |
| Date Added to Maude | 2019-04-17 |
| 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 | 2019-04-17 |
| Returned To Mfg | 2019-06-04 |
| Catalog Number | SPD2-US-060-320 |
| Lot Number | A794271 |
| 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 | 2019-04-17 |