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 2020-03-04 for CAROTID WALLSTENT 26605 manufactured by Boston Scientific Corporation.
[182208883]
Device evaluated by mfr. :the device was returned with the stent partially deployed by 9mm. Unable to deploy the stent due to an outer break and condition of device of the returned device. A visual and microscopic investigation identified no issues with the tip that could have contributed to the complaint incident. A visual and tactile examination of the device identified that the middle outer was stretched and kinked in multiple locations. The outer detached 28mm distal of the strain relief. The stainless-steel tube handle was also kinked. No other issues were identified during the product analysis.
Patient Sequence No: 1, Text Type: N, H10
[182208884]
Reportable based on device analysis completed on 18-feb-2020. It was reported that advancing difficulties were encountered. The target lesion was located in the carotid artery. A 10. 0-37 carotid wallstent was selected for use. However, the stent was unable to advance after advancing a part of it. The procedure was completed with another of the same device. There were no patient complications reported and the patient's status was stable. However, returned device analysis revealed stent partial deployment and shaft damage.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-02472 |
| MDR Report Key | 9786595 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-04 |
| Date of Report | 2020-03-04 |
| Date of Event | 2019-12-17 |
| Date Mfgr Received | 2020-02-18 |
| Device Manufacturer Date | 2019-02-04 |
| Date Added to Maude | 2020-03-04 |
| 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 | 2020-03-04 |
| Returned To Mfg | 2020-01-07 |
| Model Number | 26605 |
| Catalog Number | 26605 |
| Lot Number | 0023287136 |
| 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 | 2020-03-04 |