MAUDE Adverse Event Report: SILK ROAD MEDICAL, INC. ENROUTE TRANSCAROTID 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 Problems Patient Problem/Medical Problem (2688); Vascular Dissection (3160)

Event Date 08/18/2017

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: ENROUTE TRANSCAROTID 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: 1213 innsbruck drive; sunnyvale, CA 94089 ; 4087209002
• MDR Report Key: 9650068
• MDR Text Key: 179312262
• Report Number: 3014526664-2020-00010
• Device Sequence Number: 1
• Product Code: NTE
• UDI-Device Identifier: 00811311020744
• UDI-Public: (01)00811311020744(17)171029(10)200723
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 10/29/2017
• Device Model Number: SR-200-NPS
• Device Catalogue Number: SR-200-NPS
• Device Lot Number: 200723
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention