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 2020-01-27 for CAROTID WALLSTENT 26605 manufactured by Boston Scientific Corporation.
[178379642]
Device evaluated by mfr. : the carotid device was returned with the stent fully crimped onto the delivery system. The device was returned to the complaint investigation site with the stent fully crimped onto the delivery system. A red blood like substance was identified on the device and constrained stent. The handle was pushed passed the point of no return sticker on the stainless-steel tube and there was an outer break 180mm proximal from the distal end of the outer. The investigator was unable to deploy the stent due to the outer break. The investigator deployed by pulling on the tip distally while gripping outer. No issues were noted with the deployed stent. A visual and microscopic investigation identified no issues with the stent cup, stent holder or tip that could have contributed to the complaint incident. A visual and tactile examination of the device identified an outer break 180mm proximal from the distal end of the outer. No other issues were identified during the product analysis.
Patient Sequence No: 1, Text Type: N, H10
[178379643]
Reportable based on device analysis completed on 009jan2020. It was reported that deployment issue occurred. The target lesion was located in the right subclavian artery. A 10. 0-31 carotid wallstent was advanced for treatment. However, it was noted that stent would not release. The procedure was completed with another of the same device. No patient complications were reported and the patient's status was stable. However, returned device analysis revealed shaft detached/separated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-00501 |
| MDR Report Key | 9632492 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-01-27 |
| Date of Report | 2020-01-27 |
| Date of Event | 2019-10-08 |
| Date Mfgr Received | 2020-01-09 |
| Device Manufacturer Date | 2019-02-14 |
| Date Added to Maude | 2020-01-27 |
| 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 | 2020-01-27 |
| Returned To Mfg | 2019-11-27 |
| Model Number | 26605 |
| Catalog Number | 26605 |
| Lot Number | 0023349321 |
| 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 | 2020-01-27 |