FDA.reportPublic FDA data

MAUDE MDR 8171754

MDR report key
8171754
Report number
1649395-2018-00010
Event key
0
Event type
3
Date of event
2018-10-01
Date received
2018-12-17
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
DIYAR MEDHAT
Address
2220, 6137, MERRITT DR GARLAND TX 75041 US
Phone
972-972-9722
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1TRANSITIONLESS MICRO-INTRODUCER KITPERCUTANEOUS SHEATH INTRODUCER KITGALT MEDICAL CORP.OFLKIT-038-03KIT-038-03G18194884N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-12-170

Event Narratives#

N

Patient 1

THE DEVICE IS NOT AVAILABLE FOR EVALUATION PER HEALTH PROFESSIONAL. INVESTIGATION AND EVALUATION PERFORMED BASED ON DEVICE HISTORY REVIEW AND COMPLAINT HISTORY REVIEW. DEVICE HISTORY REVIEW SHOWS ALL UNITS WAS MANUFACTURED TO SPECIFICATIONS AND PASSED INSPECTION CRITERIA. BASED ON HISTORY RECORD FOR LAST FIVE YEARS, THIS TYPE OF INCIDENT MIGHT OCCUR DUE TO END USER ERROR. END USER MIGHT NOT FOLLOW INSTRUCTIONS PER (INSTRUCTIONS FOR USE). PER HEALTH PROFESSIONAL STATEMENT SAID (PER CARDIOLOGIST'S NOTES: A PERCUTANEOUS NEEDLE STICK WAS ACHIEVED THROUGH THE LEFT SUBCLAVIAN VEIN. A GUIDEWIRE WAS THEN INSERTED INTO THE LEFT SUBCLAVIAN VEIN. RESISTANCE WAS MET AND WHILE RETRACTING THE WIRE, THE TIP BROKE OFF). GUIDEWIRES CANNOT BE REMOVED FROM PATIENT BODY THROUGH THE NEEDLE. IF ANY OBSTRUCTIONS OR RESISTANCE OCCURRED IT IS RECOMMENDED TO REMOVE ENTIRE ASSEMBLY FROM PATIENT BODY NOT ONLY THE GUIDEWIRES. REMOVING GUIDEWIRES THROUGH THE NEEDLE MIGHT LEAD TO CUT TIP OF COILED WIRE BY CUTTING EDGES OF THE NEEDLES OR GUIDEWIRES MIGHT UNRAVELED OR TANGLED WHILE INSIDE PATIENT BODY CAUSING SERIOUS INJURY. MANUFACTURER RECOMMEND TO END USER TO FOLLOW INSTRUCTION FOR USE STATED AS WARNING (DO NOT WITHDRAW GUIDEWIRE THROUGH METAL NEEDLES; GUIDEWIRE MAY SHEAR OR UNRAVEL).

D

Patient 1

AS RECEIVED FROM HEALTH PROFESSIONAL: PATIENT WAS PREPPED/ DRAPED IN STERILE FASHION. PER CARDIOLOGIST'S NOTES: A PERCUTANEOUS NEEDLE STICK WAS ACHIEVED THROUGH THE LEFT SUBCLAVIAN VEIN. A GUIDEWIRE WAS THEN INSERTED INTO THE LEFT SUBCLAVIAN VEIN. RESISTANCE WAS MET AND WHILE RETRACTING THE WIRE, THE TIP BROKE OFF. CONTRAST ANGIOGRAPHY WAS PERFORMED DEMONSTRATING THAT THE WIRE WAS NOT INTRAVASCULAR. ACCESS WAS THEN AGAIN ACHIEVED VIA MICROPUNCTURE UNDER ANGIOGRAPHY.