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 2020-03-20 for CAROTID WALLSTENT 26605 manufactured by Boston Scientific Corporation.
[184307069]
Device evaluated by mfr: the device was returned for analysis. A visual examination found the stent to be mounted in the correct position on the delivery system. A visual and tactile inspection identified complete break of the outer shaft of the device located at the guidewire port. The inner shaft was also noted to be severely kinked at the site of the outer shaft break. This type of damage is consistent with excessive force being applied to the device. No other issues were identified during the product analysis.
Patient Sequence No: 1, Text Type: N, H10
[184307072]
Reportable based on device analysis completed on 06mar2020. It was reported that inadvertent deployment and advancing difficulties were encountered. Vascular access was obtained via the femoral artery. The 90% stenosed, 25x7mm, concentric, de novo target lesion was located in the moderately tortuous and lowly calcified right coronary artery. Pre-dilation was performed with a 2. 5x20mm emerge balloon catheter, leaving 60% stenosis. A 8. 0-29mm carotid monorail stent was advanced but had difficulty advancing. It was deployed but removed from the patient. The procedure was completed with another of the same device. No patient complications were reported and patient status was stable. However, returned device analysis revealed shaft detach/separate.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-03572 |
| MDR Report Key | 9860520 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-20 |
| Date of Event | 2019-12-03 |
| Date Mfgr Received | 2020-03-06 |
| Device Manufacturer Date | 2018-12-20 |
| Date Added to Maude | 2020-03-20 |
| 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 | 2020-03-20 |
| Returned To Mfg | 2020-02-03 |
| Model Number | 26605 |
| Catalog Number | 26605 |
| Lot Number | 0023112338 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-03-20 |