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 2020-01-30 for ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM SR-200-NPS manufactured by Silk Road Medical, Inc..
[179312262]
On 17dec2019 silk road medical contacted osb to inform them of medical device reports that were not reported within the mandatory reporting timeframe. It is noted here, per fda's request, that this mdr was identified as part of a complaint handling remediation effort associated with capa-(b)(4). 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 identified that could lead to the adverse event reported. Complaints will continue to be monitored for any trends.
Patient Sequence No: 1, Text Type: N, H10
[179312263]
Patient underwent tcar procedure. The arterial sheath was advanced over the guidewire and went in smoothly under angiography, with wire never advancing, and was then sutured into place. Dissection noted at the tip of the arterial sheath when taking 2 views. Attempts were made to pull back arterial sheath to allow wire into true lumen. Original access point was closed, and the physician attempted the process again. Angio revealed dissection, but md did not feel he was in true lumen and did not wish to try and pass wires at this time. Decision was made to abandon transcarotid revascularization procedure, and convert treatment to cea. Patient did well and woke up post procedure neurologically intact.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3014526664-2020-00010 |
| MDR Report Key | 9650068 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-30 |
| Date of Report | 2020-01-30 |
| Date of Event | 2017-08-18 |
| Date Added to Maude | 2020-01-30 |
| 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 Street | 1213 INNSBRUCK DRIVE |
| Manufacturer City | SUNNYVALE CA 94089 |
| Manufacturer Country | US |
| Manufacturer Postal | 94089 |
| Manufacturer Phone | 4087209002 |
| Manufacturer G1 | SILK ROAD MEDICAL, INC. |
| Manufacturer Street | 1213 INNSBRUCK DRIVE |
| Manufacturer City | SUNNYVALE CA 94089 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94089 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM |
| Generic Name | TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE |
| Product Code | NTE |
| Date Received | 2020-01-30 |
| Model Number | SR-200-NPS |
| Catalog Number | SR-200-NPS |
| Lot Number | 200723 |
| Device Expiration Date | 2017-10-29 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SILK ROAD MEDICAL, INC. |
| Manufacturer Address | 1213 INNSBRUCK DRIVE SUNNYVALE CA 94089 US 94089 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-30 |