FDA.reportPublic FDA data

MAUDE MDR 9699683

MDR report key
9699683
Report number
2126666-2020-00007
Event key
0
Event type
3
Date of event
2020-01-21
Date received
2020-02-12
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
SHARON SEIFERT
Address
340 LAKE HAZELTINE DRIVE CHASKA, MN US
Phone
641-641-6418
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1THRUWAY GUIDEWIREWIRE, GUIDE, CATHETERLAKE REGION MEDICALDQXM00149297149-29711164028Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-02-1201. R

Event Narratives#

N

Patient 1

THE DEVICE WAS NOT RECEIVED FOR ANALYSIS AT THE TIME OF THIS REPORT; THEREFORE NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT CAN BE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORDS OF THE SPECIMEN DEVICE DOES NOT PRESENT ANY INDICATION OF MANUFACTURING DEFECT OR ANOMALY THAT COULD HAVE IMPACTED ON THE EVENT AS REPORTED. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. AS NOTED IN THE PRECAUTIONS PORTION OF THE THRUWAY DEVICE INSTRUCTIONS FOR USE, "DO NOT TORQUE, ADVANCE OR WITHDRAW THE GUIDEWIRE IF SIGNIFICANT RESISTANCE IS FELT. TORQUING, ADVANCING OR WITHDRAWING A GUIDEWIRE AGAINST SIGNIFICANT RESISTANCE MAY CAUSE VESSEL DAMAGE, GUIDEWIRE DAMAGE AND/OR GUIDEWIRE TIP SEPARATION." AT THIS TIME IT IS NOT POSSIBLE TO ASSIGN A DEFINITIVE ROOT CAUSE FOR THE EVENT AS REPORTED. BASED ON THE INFORMATION PROVIDED TO DATE, IT APPEARS THAT CLINICAL AND/OR PROCEDURAL FACTORS MAY HAVE IMPACTED ON THE EVENT AS REPORTED. THE PATIENT INFORMATION WAS NOT PROVIDED AT THE TIME OF THIS REPORT. IF ANY FURTHER RELEVANT INFORMATION IS PROVIDED, A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED.

D

Patient 1

IT WAS REPORTED THAT: DURING A JETSTREAM CASE, THE WIRE TIP BROKE OFF THE END OF THE WIRE AND BECAME LODGED IN THE SFA VESSEL. THE WIRE DID NOT MOVE AND COULD NOT BE RETRIEVED SO A STENT WAS PLACED OVER THE WIRE TIP TO HOLD IT IN PLACE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED.