FDA.reportPublic FDA data

MAUDE MDR 9644449

MDR report key
9644449
Report number
3005168196-2020-00111
Event key
0
Event type
3
Date of event
2020-01-07
Date received
2020-01-29
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
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.QEWCAT6KIT-ACAT6KITF90553 R
101---

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-01-290

Event Narratives#

N

Patient 1

THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION RESULTS ARE PENDING. A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION.

D

Patient 1

THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA) AND POPLITEAL ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6) AND NON-PENUMBRA SHEATH. IT WAS REPORTED THAT THE PATIENT?S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY ASPIRATED THE CLOT FROM THE UPPER SFA USING THE CAT6 WITHOUT A PEAL AWAY SHEATH AND THE SHEATH. NEXT, WHILE ADVANCING THE CAT6 THROUGH THE SHEATH IN A MORE TORTUOUS SECTION OF THE TARGET VESSEL, THE PHYSICIAN FELT THE CAT6 KINKED; THEREFORE, IT WAS REMOVED. UPON REMOVAL, THE PHYSICIAN OBSERVED THE KINK. THE PROCEDURE WAS COMPLETED USING AN INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX) AND ANOTHER NON-PENUMBRA SHEATH. IT WAS NOTED THAT NOT ALL OF THE CLOT IN THE DISTAL POPLITEAL ARTERY WAS REMOVED DUE TO THE CATRX BEING TOO SMALL. SUBSEQUENTLY, THE PHYSICIAN ADMINISTERED DRIPPING FOR THE PATIENT AND WILL PERFORM ANOTHER PROCEDURE USING ANOTHER CAT6 THE NEXT DAY. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.