FDA.reportPublic FDA data

MAUDE MDR 9751195

MDR report key
9751195
Report number
3014526664-2020-00043
Event key
0
Event type
3
Date of event
2020-02-13
Date received
2020-02-25
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Address
1213 INNSBRUCK DRIVE SUNNYVALE, CA US
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ENROUTE NEUROPROTECTION SYSTEMTEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURESILK ROAD MEDICAL, INCNTESR-200-NPSSR-200-NPS300898R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-02-2501. R

Event Narratives#

N

Patient 1

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.

D

Patient 1

IT WAS REPORTED THAT A (B)(6) YEAR OLD MALE UNDERWENT A RIGHT TRANSCAROTID REVASCULARIZATION PROCEDURE ON (B)(6) 2020. AFTER ACCESS WAS GAINED WITH A MICROPUNCTURE KIT, IMAGING WAS PERFORMED WHICH SHOWED NO DISSECTION AT THIS TIME. THE PHYSICIAN ADVANCED THE .035 STIFF WIRE WITH NO RESISTANCE AND EXCHANGED THE MPK SHEATH FOR THE ARTERIAL SHEATH. A FEW IMAGES WERE TAKEN AND A DISSECTION WAS NOTED. THE PHYSICIAN DISCONNECTED THE FLOW REVERSAL AND REMOVED THE ARTERIAL SHEATH AND CLOSED PUNCTURE SITE. THE PHYSICIAN DECIDED TO CONVERT TO A TRANSFEMORAL CAS AND PLACED TWO STENTS TO FIX THE LESION AND THEN COVER THE DISSECTION. THE ACCESS SITE WAS THEN CLOSED. PATIENT WOKE UP FROM ANESTHESIA WITH NO COMPLICATIONS. NO ADDITIONAL DETAILS WERE PROVIDED.