FDA.reportPublic FDA data

MAUDE MDR 9862758

MDR report key
9862758
Report number
3014526664-2020-00047
Event key
0
Event type
3
Date of event
2020-02-24
Date received
2020-03-20
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#

Contact
MS. SHARON RIDEOUT
Address
1213 INNSBRUCK DRIVE SUNNYVALE, CA US
Phone
720-720-7209
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ENROUTE NEUROPROTECTION SYSTEMNPASILK ROAD MEDICALNTESR-200-NPSSR-200-NPS300898R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-2001. 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

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.