MAUDE Adverse Event Report: SILK ROAD MEDICAL, INC. ENROUTE NEUROPROTECTION SYSTEM; TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE

Model Number SR-200-NPS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Infarction, Cerebral (1771)

Event Date 04/02/2019

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing records for this device was completed and no issues were identified that could have lead to the adverse event reported.Additionally, this was the first reported adverse event of this nature associated with this lot.Therefore, the root cause of this adverse event cannot be identified at this time.

Event Description

Tcar procedure was performed.Patient was still sedated after returning from the icu and had weakness on the left side of his arm."code stroke" was called and the patient was sent to get a ct scan.No bleeding was reported to the physician.After returning from the ct scan, patient left arm was moving.

• Brand Name: ENROUTE NEUROPROTECTION SYSTEM
• Type of Device: TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE
• Manufacturer (Section D): SILK ROAD MEDICAL, INC.; 1213 innsbruck drive; sunnyvale CA 94089
• Manufacturer (Section G): SILK ROAD MEDICAL, INC.; 1213 innsbruck drive; sunnyvale CA 94089
• Manufacturer Contact: mai-ly wilcox ; 1213 innsbruck drive; sunnyvale, CA 94089
• MDR Report Key: 8524404
• MDR Text Key: 142263898
• Report Number: 3014526664-2019-00025
• Device Sequence Number: 1
• Product Code: NTE
• UDI-Device Identifier: 00811311020829
• UDI-Public: (01)00811311020829(17)201026(10)300203
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153485
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/26/2020
• Device Model Number: SR-200-NPS
• Device Catalogue Number: SR-200-NPS
• Device Lot Number: 300203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/02/2019
• Initial Date FDA Received: 04/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/27/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 80 YR