FDA.reportPublic FDA data

MAUDE MDR 9764074

MDR report key
9764074
Report number
3005168196-2020-00253
Event key
0
Event type
3
Date of event
2020-02-06
Date received
2020-02-27
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. VERONICA FARRIS
Address
ONE PENUMBRA PLACE ALAMEDA CA 94502 US
Phone
510-510-5107
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1INDIGO SYSTEM ASPIRATION CATHETER 6QEWPENUMBRA, INC.QEWCAT6CAT6F90726 N
101---

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-02-270

Event Narratives#

N

Patient 1

THE PRODUCT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE DEVICE, THE ROOT CAUSE OF THE PROBLEM CANNOT BE DETERMINED. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS.

D

Patient 1

THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE POPLITEAL ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6) AND NON-PENUMBRA SHEATH. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE THE CAT6 INTO THE ROTATING HEMOSTASIS VALVE (RHV) OF THE SHEATH, THE DISTAL END OF THE CAT6 KINKED; THEREFORE, IT WAS REMOVED. IT WAS NOTED THAT THE CAT6 WAS BEING USED WITH A PEEL AWAY SHEATH BUT WITHOUT A GUIDEWIRE. THE PROCEDURE WAS COMPLETED USING ANOTHER CAT6 WITH THE PEEL AWAY SHEATH OF AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8), GUIDEWIRE, AND THE SAME SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.