FDA.reportPublic FDA data

MAUDE MDR 6735039

MDR report key
6735039
Report number
2032493-2017-00173
Event key
0
Event type
3
Date of event
2017-05-11
Date received
2017-07-23
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. DEBBY CALLAHAN
Address
1311 VALENCIA AVENUE TUSTIN CA 92780 US
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1TRAXCESS 7 MINIGUIDE WIREMICROVENTION, INC.MOFGW0721006M17030521Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-07-230

Event Narratives#

N

Patient 1

THE LOT NUMBER WAS PROVIDED. A REVIEW OF THE APPROVED DEVICE HISTORY RECORDS INDICATED THE LOT MET ALL RELEASE CRITERIA. A LOT HISTORY TRENDING REVIEW WAS PERFORMED AND THERE WERE NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER. THE DEVICE WAS RETURNED FOR EVALUATION IN ITS ORIGINAL PACKAGING, WITHOUT ITS INTRODUCER. UPON INVESTIGATION, A SECTION OF COATING CAME OFF 146CM FROM THE DISTAL TIP. WITHOUT THE SYNCHRO 2 INSERTION TOOL USED IN THE PROCEDURE, IT IS UNABLE TO CONFIRM IF THERE WERE ANY ROUGH EDGES OR BURS IN THE TOOL WHICH COULD HAVE CAUSED THE COATING TO COME OFF. THE RETURNED GUIDEWIRE WAS HYDRATED AND INTRODUCED THROUGH A NEW TRAXCESS INTRODUCER IN WHICH NO ADDITIONAL COATING CAME OFF. BASED UPON THE INVESTIGATION FINDINGS AND AVAILABLE INFORMATION, THE REPORTED COMPLAINT WAS CONFIRMED; HOWEVER, THE ROOT CAUSE CANNOT BE DETERMINED.

D

Patient 1

IT WAS REPORTED THAT THE TRAXCESS GUIDEWIRE WAS REMOVED FROM THE PATIENT TO RE-SHAPE THE TIP. PRIOR TO RE-USE IN THE PATIENT, THE INSERTION TOOL WAS BACKLOADED ONTO THE GUIDEWIRE AND DURING THE PROCESS, THE COATING APPEARED TO STRIP OFF THE GUIDEWIRE. THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT'S CURRENT STATUS IS REPORTED TO BE STABLE.