FDA.reportPublic FDA data

MAUDE MDR 6868547

MDR report key
6868547
Report number
6868547
Event key
0
Event type
3
Date of event
2017-08-03
Date received
2017-09-15
Adverse event
0
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1HYDRO LEMAITRE VALVULOTOMEVALVULOTOMELEMAITRE VASCULAR, INC.MGZ1009-001009-00ELVH1058R Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-09-150

Event Narratives#

N

Patient 1

D

Patient 1

THE VALVULOTOME GOT STUCK AS THE SURGEON WAS PULLING OUT OF THE VEIN. UPON INSPECTION, THE SURGEON NOTED THAT ONE OF THE RIDGES DID NOT FULLY RETRACT. PRODUCT HAD PATIENT CONTACT BUT NO PATIENT HARM. ANOTHER VALVULOTOME WAS OPENED AND USED TO COMPLETE THE PROCEDURE. MANUFACTURER RESPONSE FOR VALVULOTOME HYDROPHILIC 1.5 MM, (BRAND NOT PROVIDED) (PER SITE REPORTER): PRODUCT FAILURE QUESTIONNAIRE. WAITING FOR RESPONSE AND RMA.