FDA.reportPublic FDA data

MAUDE MDR 7463584

MDR report key
7463584
Report number
3003775027-2018-00090
Event key
0
Event type
3
Date of event
2017-08-03
Date received
2018-04-26
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
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ASAHI CHIKAI BLACK 14NEUROVASCULAR GUIDE WIREASAHI INTECC CO., LTD.MOFNAAIN-CKI-200-B-SFT170522A16AR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-04-260

Event Narratives#

N

Patient 1

(B)(4). ATTEMPTS WERE MADE TO GATHER THOROUGH EVENT INFORMATION DURING COMPLAINT PROCESSING; NO FURTHER INFORMATION COULD BE OBTAINED. DEVICE INVESTIGATION COULD NOT BE PERFORMED BECAUSE THE DEVICE WAS NOT RETURNED. LOT HISTORY REVIEW REVEALED NO ANOMALY RELATING TO THE REPORTED EVENT AND NO OTHER SIMILAR PRODUCT EXPERIENCE REPORT WAS RECEIVED FOR THIS LOT. REVIEWING OF THE MANUFACTURING RECORDS CONFIRMED NO INDICATION OF PRODUCT DEFICIENCY. DUE TO LIMITED INFORMATION AND AS DEVICE INVESTIGATION COULD NOT BE PERFORMED, INVOLVEMENT OF THE SUBJECT GUIDE WIRE TO THE REPORTED BLEEDING COULD NOT BE ASCERTAINED; THEREFORE, A POSSIBILITY THAT THE GUIDE WIRE MIGHT CAUSE OR CONTRIBUTE TO THE REPORTED BLEEDING COULD NOT BE COMPLETELY RULED OUT. MALFUNCTIONS AND ADVERSE EFFECTS SECTION OF THE INSTRUCTIONS FOR USE (IFU) STATES BLEEDING COMPLICATIONS.

D

Patient 1

IT WAS REPORTED THAT SMALL BLEEDING OCCURRED AFTER A PROCEDURE TO TREAT AN ANEURYSM WHERE AN ASAHI GUIDE WIRE WAS USED. REPORTEDLY NO ADDITIONAL INTERVENTION WAS PERFORMED AGAINST THIS BLEEDING. THE PATIENT HAD BEEN UNDER A ROUTINE OUTPATIENT MONITORING.