FDA.reportPublic FDA data

MAUDE MDR 6337985

MDR report key
6337985
Report number
3003775027-2017-00019
Event key
0
Event type
3
Date of event
2017-01-16
Date received
2017-02-16
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
YUKAKO HOMMA
Address
3-100 AKATSUKI-CHO SETO, AICHI 489-0 JA
Phone
561-561-5614
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI 008NEUROVASCULAR GUIDE WIREASAHI INTECC CO., LTD.MOFNAWAIN-CKI-008-200161019A04AY R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-02-1601. O

Event Narratives#

N

Patient 1

(B)(4). ALTHOUGH ATTEMPTS WERE MADE TO GATHER THOROUGH EVENT INFORMATION DURING COMPLAINT PROCESSING, NO FURTHER INFORMATION COULD BE OBTAINED. THE RETURNED GUIDEWIRE WAS OBSERVED. THERE WAS NO NOTABLE ABNORMALITY OR DEFORMITY FOUND ON THE GUIDEWIRE. LOT HISTORY REVIEW REVEALED NO ANOMALY RELATING TO THE REPORTED EVENT AND NO OTHER SIMILAR PRODUCT EXPERIENCE REPORT WAS RECEIVED. BASED ON THE PROVIDED INFORMATION AND THE INVESTIGATION OUTCOME, IT WAS CONCLUDED THAT THE RETURNED CHIKAI 008 GUIDEWIRE HAD NO NOTABLE ABNORMALITY THAT AFFECTED THE WIRE LUBRICITY. STUCK OCCURRED BETWEEN THE GUIDEWIRE AND THE MICROCATHETER WAS THOUGHT TO BE RELATED TO VESSEL TORTUOSITY, VESSEL CIRCUMFLEX, AND/OR BLOOD THAT ENTERED INTO THE MICROCATHETER THAT TEMPORARILY RESTRICTED THE WIRE LUBRICITY. REPORTED ABNORMALITY FOUND APPROXIMATELY 3-5CM PROXIMAL TO THE DISTAL TIP WAS NOT FOUND ON THE GUIDEWIRE; IT WAS PERHAPS THE MIDDLE SOLDER THAT LOOKED LIKE A MARKER BAND. IT WAS PRESUMED THAT UNRAVELING OF THE EMBOLIZATION COIL OCCURRED DURING REMOVAL OF THE DEVICES WHILE THE DISTAL END OF THE GUIDEWIRE OR THE CATHETER WAS TRAPPED BY THE COIL; HOWEVER, WHICH DEVICE CONTRIBUTED TO UNRAVELING OF THE COIL COULD NOT BE DETERMINED. THE WARNINGS SECTION OF THE IFU STATES: OBSERVE MOVEMENT OF THIS DEVICE IN THE VESSELS. BEFORE THIS DEVICE IS MOVED OR TORQUED, THE TIP MOVEMENT SHOULD BE EXAMINED AND MONITORED UNDER FLUOROSCOPY. DO NOT MOVE OR TORQUE THE DEVICE WITHOUT OBSERVING CORRESPONDING MOVEMENT OF THE TIP. OTHERWISE, THE DEVICE MAY BE DAMAGED AND/OR VESSEL TRAUMA MAY OCCUR. IN ADDITION, ENSURE THAT THE DISTAL TIP OF THIS DEVICE AND ITS LOCATION IN THE VESSEL ARE VISIBLE DURING MANIPULATIONS OF THE DEVICE; NEVER PUSH, AUGER, WITHDRAW, OR PRESS THIS DEVICE WITH ENOUGH FORCE TO FEEL RESISTANCE. PRESSING OR PUSHING THIS DEVICE AGAINST RESISTANCE MAY CAUSE DAMAGE AND/OR TIP SEPARATION OF THIS DEVICE OR DIRECT DAMAGE TO A VESSEL. RESISTANCE MAY BE FELT AND/OR OBSERVED UNDER FLUOROSCOPY BY NOTING ANY BUCKLING OF THE TIP OF THE DEVICE. IF THE PROLAPSE OF THE DEVICE TIP IS OBSERVED, DO NOT ALLOW THE TIP TO REMAIN IN A PROLAPSED POSITION. OTHERWISE DAMAGE TO THE DEVICE MAY OCCUR. DETERMINE THE CAUSE OF RESISTANCE UNDER FLUOROSCOPY AND TAKE ANY NECESSARY REMEDIAL ACTION; AND, IF ANY RESISTANCE IS FELT DUE TO SPASM OR THE DEVICE BEING BENT OR TRAPPED WHILE OPERATING THE DEVICE IN THE BLOOD VESSEL OR REMOVING IT, DO NOT MOVE OR TORQUE THE DEVICE. STOP THE PROCEDURE. DETERMINE THE CAUSE OF RESISTANCE UNDER FLUOROSCOPY AND TAKE APPROPRIATE REMEDIAL ACTION. IF THE DEVICE IS MOVED EXCESSIVELY, IT MAY BREAK OR BECOME DAMAGED, WHICH MAY CAUSE BLOOD VESSEL INJURY OR RESULT IN FRAGMENTS BEING LEFT INSIDE THE VESSEL.

D

Patient 1

DURING AVM EMBOLIZATION, AN ASAHI GUIDEWIRE WAS USED WITH A 1.3 FR. MICROCATHETER (MANUFACTURER UNKNOWN). WHEN THE GUIDEWIRE WAS ADVANCED INSIDE THE AVM FOLLOWED BY THE MICROCATHETER, THE GUIDEWIRE WOULD NOT ADVANCE NOR RETRACT INSIDE THE MICROCATHETER SO THAT BOTH DEVICES WERE REMOVED SIMULTANEOUSLY FROM THE LESION. UPON REMOVAL FROM THE LESION, UNDER FLUOROSCOPY, A LOOP OF COIL WAS INADVERTENTLY REMOVED FROM THE PREVIOUSLY EMBOLIZED LESION ALONG WITH THE GUIDEWIRE AND MICROCATHETER. AN IRREGULAR CONTOUR OR A BULBOUS SEGMENT WAS OBSERVED ON THE GUIDEWIRE APPROXIMATELY 3-5CM PROXIMAL TO THE DISTAL TIP (AS IF THE GUIDEWIRE ITSELF HAD A MARKER BAND AROUND THE WIRE). THE COIL LOOP WAS LEFT IN PLACE AND PROCEDURE WAS HALTED. THERE WAS NO HEALTH IMPACT ON THE PATIENT.