MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-03-10 for CAROTID WALLSTENT 26606 manufactured by Boston Scientific Corporation.
[182737230]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
[182737231]
It was reported that partial deployment occurred. The target lesion was located in the carotid artery. After dilation was performed with a non-bsc balloon catheter, a 10. 0-24 carotid wallstent stent was advanced for treatment; however, only about 80% was deployed and the outer sheath got stuck. Since the stent could not be deployed while being stuck, the area of the stent that was already deployed and the guiding catheter was advanced over the deployed part of the stent for removal. The procedure was completed with another of the same device. There were no patient complications nor injuries reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-02499 |
| MDR Report Key | 9811759 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-10 |
| Date of Report | 2020-03-10 |
| Date of Event | 2020-02-13 |
| Date Mfgr Received | 2020-02-17 |
| Device Manufacturer Date | 2019-11-15 |
| Date Added to Maude | 2020-03-10 |
| 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 CORPORATION |
| Manufacturer Street | BALLYBRIT BUSINESS PARK |
| Manufacturer City | GALWAY |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAROTID WALLSTENT |
| Generic Name | STENT, CAROTID |
| Product Code | NIM |
| Date Received | 2020-03-10 |
| Returned To Mfg | 2020-03-03 |
| Model Number | 26606 |
| Catalog Number | 26606 |
| Lot Number | 0024774934 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-03-10 |