FDA.reportPublic FDA data

MAUDE MDR 9832928

MDR report key
9832928
Report number
3005168196-2020-00366
Event key
0
Event type
3
Date of event
2020-02-15
Date received
2020-03-14
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
1PENUMBRA SYSTEM JET7 REPERFUSION CATHETERNRYPENUMBRA, INC.NRY5MAXJET7-B5MAXJET7F93838 R
101---

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-140

Event Narratives#

N

Patient 1

THE FOLLOWING DEVICE CODE ALSO APPLIES TO THIS COMPLAINT: 1069 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 M1 OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7), VELOCITY DELIVERY MICROCATHETER (VELOCITY) AND A NON-PENUMBRA GUIDING SHEATH. DURING THE PROCEDURE, THE PHYSICIAN DILATED THE RADIAL ARTERY, ADVANCED THE GUIDING SHEATH ALONG WITH THE DILATOR DIRECTLY THROUGH THE SKIN TO THE INTERNAL CAROTID ARTERY (ICA) AND THEN REMOVED THE DILATOR. WHILE ADVANCING THE JET7 AND VELOCITY THROUGH THE CHECK-FLO HEMOSTATIC VALVE ON THE GUIDING SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE JET7 WOULD NO LONGER ADVANCE; THEREFORE, IT WAS REMOVED. UPON REMOVAL OF THE JET7, IT WAS NOTICED THAT THE JET7 STRETCHED AND THE DISTAL END OF THE JET7 BROKE OFF. IT WAS REPORTED THAT THE BROKEN PIECE OF THE JET7 WAS STUCK IN THE PROXIMAL END OF THE GUIDING SHEATH WITH THE BROKEN PIECE OF THE JET7 HANGING OUT OF THE DISTAL END OF THE GUIDING SHEATH. THE PHYSICIAN THEN REMOVED THE WHOLE SYSTEM FROM THE PATIENT WITH BOTH THE GUIDING SHEATH AND REMAINING BROKEN PIECE OF THE JET7. THE PROCEDURE WAS COMPLETED USING A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER (ACE68), SAME CHECK-FLO HEMOSTATIC VALVE AND A NEW GUIDING SHEATH. IT WAS REPORTED THAT AFTER THE DILATOR WAS REMOVED FROM THE GUIDING SHEATH, THE CHECK-FLO HEMOSTATIC VALVE CONTAINED SOME COIL WIND THAT THE PHYSICIAN BELIEVED MAY HAVE BEEN STUCK IN THE VALVE FROM THE BROKEN JET7. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.