MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-20 for ENROUTE NEUROPROTECTION SYSTEM SR-200-NPS manufactured by Silk Road Medical.
[189082186]
The product in complaint was not returned to the manufacturer for analysis. A review of the manufacturing records for this device was completed and no issues were identifed that could have lead to the adverse event reported. Complaints will continue to be monitored for any trends.
Patient Sequence No: 1, Text Type: N, H10
[189082187]
A left tcar procedure was performed under general sedation. The physician noticed that the tip of the arterial sheath had been pulled back during the sheath tip angiogram. In attempting to rewire and advance the arterial sheath, the 0. 035 j-wire prolapsed as soon as it exited the sheath. Angiography revealed a dissection. The arterial sheath was pulled back in order to find the true lumen. Lesion was crossed and stented; secondary stent was placed to cover the dissection. Patient recovered with no issues.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3014526664-2020-00047 |
| MDR Report Key | 9862758 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-20 |
| Date of Event | 2020-02-24 |
| Date Mfgr Received | 2020-02-24 |
| Device Manufacturer Date | 2019-07-22 |
| 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 | MS. SHARON RIDEOUT |
| Manufacturer Street | 1213 INNSBRUCK DRIVE |
| Manufacturer City | SUNNYVALE, CA |
| Manufacturer Country | US |
| Manufacturer Phone | 7209002 |
| Manufacturer G1 | SILK ROAD MEDICAL |
| Manufacturer Street | 1213 INNSBRUCK DRIVE |
| Manufacturer City | SUNNYVALE, CA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENROUTE NEUROPROTECTION SYSTEM |
| Generic Name | NPA |
| Product Code | NTE |
| Date Received | 2020-03-20 |
| Model Number | SR-200-NPS |
| Catalog Number | SR-200-NPS |
| Lot Number | 300898 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SILK ROAD MEDICAL |
| Manufacturer Address | 1213 INNSBRUCK DRIVE SUNNYVALE, CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-20 |