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 2019-04-30 for SPIDER FX SPD2-040-190 manufactured by Covidien.
[143529871]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[143529872]
It was reported that a physician was attempting to use a 4mm spider fx with a non-medtronic sheath during the treatment of a severely calcified lesion, presenting 80 stenosis in the acvb. The spider was being used to remove a dislodged non-medtronic stent. The lesion was initially pre-dilated with an nc balloon and the non-medtronic stent was only advanced into the proximal bypass and then got stuck due to friction. It is not possible to advance or return the stent further. The stent dislodged, and after numerous attempt to retrieve the stent, the spider gasped the stent and was being withdrawn from the aortic bypass anastomosis. At the same time, however, the protection system presented in the bypass must also be withdrawn through the stenosed bypass body, for which considerable friction must be overcome. The conglomerate of deformed stent, micro-snare and protection system can not be recovered in the guiding catheter. The spider got lost during the procedure, detached, and embolized in the arteria brachialis. The detached component(s) were removed via surgery. No further patient injury reported for this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183870-2019-00194 |
| MDR Report Key | 8564019 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-04-30 |
| Date of Report | 2019-04-30 |
| Date of Event | 2019-03-12 |
| Date Mfgr Received | 2019-04-09 |
| Device Manufacturer Date | 2018-11-20 |
| Date Added to Maude | 2019-04-30 |
| 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 | 2019-04-30 |
| Catalog Number | SPD2-040-190 |
| Lot Number | A742978 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 | 2019-04-30 |