FDA.reportPublic FDA data

MAUDE MDR 1493419

MDR report key
1493419
Report number
1220948-2009-00008
Event key
0
Event type
3
Date of event
2009-09-10
Date received
2009-10-01
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Address
63 SECOND AVENUE BURLINGTON MA 01803 US
Phone
781-781-7812
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1MOLLRING CUTTERMOLLRING CUTTERLEMAITRE VASCULAR, INC.DWXMRC4407MOL1014Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12009-10-0101. O; 2. R

Event Narratives#

D

Patient 1

DISTAL RING BLADE OF MOLLRING CUTTER BROKE OFF DURING THE CUTTING MANEUVER AND REMAINED IN THE VESSEL. MOLLRING BLADE LEFT IN THE ARTERY BECAUSE IT DOES NOT FORESEE ANY DANGER TO THE PT. NO CHANGE IN PT TREATMENT WAS MADE. PT IS DOING OKAY.

N

Patient 1

THE DEVICE WAS EVALUATED AND WE ARE ABLE TO CONFIRM THAT DISTAL RING WAS DETACHED AND A CLEAN BREAK WAS SEEN. THE EVAL WAS INCONCLUSIVE ON THE ROOT CAUSE OF THE DEVICE FAILURE. HOWEVER, THE SUPPLIER WAS NOTIFIED. THE DEVICE HISTORY RECORDS FOR LOT MOL1014 REVIEW DID NOT REVEAL ANY DISCREPANCY TO THE COMPLAINT EVENT DURING EITHER THE MANUFACTURING OR THE PACKAGING PROCESS. THERE ARE NO UNRESOLVED ISSUES.