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 2020-01-07 for CAROTID WALLSTENT 26605 manufactured by Boston Scientific Corporation.
[177605099]
Device evaluated by mfr: the stent was not returned for analysis. A visual and tactile inspection identified complete break of the outer and inner shaft of the device located at the guidewire port. This type of damage is consistent with excessive force being applied to the device. The distal detached section of the device including the inner and outer shaft, the markerbands, the stent and the tip were not returned for analysis. No other issues were identified during the product analysis.
Patient Sequence No: 1, Text Type: N, H10
[177605100]
Reportable based on device analysis completed on 23-dec-2019. It was reported that sheath kink occurred. The target lesions were located in the common carotid artery. A 10. 0-37mm carotid monorail stent was selected for use; however, it was noted that the sheath was kinked 3-4cm from the distal tip. The procedure was completed with another of the same device. No patient complications were reported and the patient status was good. However, returned device analysis revealed shaft break.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2019-16470 |
| MDR Report Key | 9558332 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-01-07 |
| Date of Report | 2020-01-07 |
| Date of Event | 2019-11-11 |
| Date Mfgr Received | 2019-12-23 |
| Device Manufacturer Date | 2018-12-10 |
| Date Added to Maude | 2020-01-07 |
| 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 | 2020-01-07 |
| Returned To Mfg | 2019-11-27 |
| Model Number | 26605 |
| Catalog Number | 26605 |
| Lot Number | 0023060262 |
| 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 | 2020-01-07 |