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 2020-03-17 for VORTX - 35 83095 manufactured by Boston Scientific Corporation.
[183874760]
It was reported that coil fracture occurred. A 2mmx4mm vortx- 35 coil was selected for use localization with coil procedure prior to radiotherapy of a lung tumor. The target lesion was a mild to none tortuous. During the procedure, the coil was introduced into the non-bsc catheter, a guidewire was used to push the coil through the catheter. The coil was intermittent flushed out. When the distal part of the coil came out of the tip of the catheter it was noticed that the coil was very stretched and did not form the shape. The physician pulled out the guidewire and noticed that there was a very thin wire of the coil located at the hub. The coil was removed with the catheter from the patient by pulling out the catheter. The procedure was successfully completed with another of the coil and catheter devices and everything was fine. There were no patient complications reported and the patient was ok post procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-03381 |
| MDR Report Key | 9842389 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-17 |
| Date of Event | 2020-03-06 |
| Date Mfgr Received | 2020-03-06 |
| Device Manufacturer Date | 2019-10-10 |
| Date Added to Maude | 2020-03-17 |
| 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 | JAY JOHNSON |
| Manufacturer Street | TWO SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal | 55311 |
| Manufacturer Phone | 7634942574 |
| Manufacturer G1 | BOSTON SCIENTIFIC CORK LIMITED |
| Manufacturer Street | MODEL FARM ROAD |
| Manufacturer City | CORK |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VORTX - 35 |
| Generic Name | DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION |
| Product Code | KRD |
| Date Received | 2020-03-17 |
| Model Number | 83095 |
| Catalog Number | 83095 |
| Lot Number | 0024575560 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | TWO SCIMED PLACE MAPLE GROVE MN 55311 US 55311 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-17 |