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 2020-03-23 for CAROTID WALLSTENT 26605 manufactured by Boston Scientific Corporation.
[184472696]
(b)(6). Device evaluated by mfr. : the device was returned for analysis. A visual and tactile examination of the device identified a shaft break was observed 345mm proximal from the distal end of the tip. The device was returned with the stent fully constrained in the device. No issues were noted with the constrained stent. The stent was unable to deploy due to the shaft break. The stent deployed by manually pulling the tip while gripping the outer. No issues were noted with the stent, stent holder or stent cups. A red blood like substance was observed in the device. A visual and microscopic investigation identified no issues with the tip that could have contributed to the complaint incident. No other issues were identified during the product analysis.
Patient Sequence No: 1, Text Type: N, H10
[184472697]
Reportable based on device analysis completed on (b)(6) 2020. It was reported that deployment failure occurred. The target lesion was located in the common carotid artery. A 10. 0-24 carotid monorail stent was advanced for treatment. However, it was observed that the stent did not deploy after the t- connector was completely pulled. The procedure was completed with another of the same device. No patient complications were reported and patient's status was stable. However, returned device analysis revealed shaft detachment/separation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-03683 |
| MDR Report Key | 9865678 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-23 |
| Date of Event | 2020-01-20 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2017-01-26 |
| Date Added to Maude | 2020-03-23 |
| 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 | 2020-03-23 |
| Returned To Mfg | 2020-02-06 |
| Model Number | 26605 |
| Catalog Number | 26605 |
| Lot Number | 0020178182 |
| 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 | 2020-03-23 |