MAUDE MDR 5332380

MDR report key
5332380
Report number
3007208013-2015-00038
Event key
0
Event type
3
Date of event
2015-11-13
Date received
2015-12-16
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. VICTORIA ROGERS
Address
3034 OWEN DR ANTIOCH TN 37013 US
Phone
800-800-8002
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SYMMETRY VEIN STRIPPERDISPOSABLE VEIN STRIPPERSYMMETRY SURGICAL INC.GAJ63-403163-4031205107R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-12-1601. R

Event Narratives#

D

Patient 1

SURGEON: MR. (B)(6) (REGULAR USER OF PRODUCT) PERFORMED A VARICOSE VEIN PROCEDURE ON ONE LEG OF PATIENT WITH SUCCESS, AND THEN USED THE SAME LINE AND A NEW OLIVE FOR THE SECOND LEG OF THE SAME PATIENT. PRODUCT SPECIALIST CANNOT CONFIRM IF TENSION OF THE LINE OR LOADING WAS CHECKED BY THE SURGEON OR MEDICAL STAFF BEFORE PERFORMING THE SECOND LEG. THE SURGEON INSERTED THE LINE ON THE SECOND LEG BUT ON REMOVAL, THE OLIVE TIP AND THE VEIN REMAINED IN THE SITU. RETRIEVAL WAS NOT PERFORMED ON THE DATE OF INCIDENT. THE SURGEON WAS NOT PREPARED TO DO SO AS THE PATIENT WAS LARGE AND HAS LARGE DERMATITIS LEGS. PATIENT WAS STABLE AND DISCHARGED FROM HOSPITAL ON (B)(6) 2015. RETRIEVAL SURGERY BOOKED FOR (B)(6) 2015.