FDA.reportPublic FDA data

MAUDE MDR 9774241

MDR report key
9774241
Report number
2029214-2020-00179
Event key
0
Event type
3
Date of event
2020-02-12
Date received
2020-03-02
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
MGR. KATCHA TAYLOR
Address
9775 TOLEDO WAY IRVINE CA 92618 US
Phone
949-949-9496
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1HYPERGLIDECATHETER, INTRAVASCULAR OCCLUDING, TEMPORARYMICRO THERAPEUTICS, INC. DBA EV3MJN104-4112A848770N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-020

Event Narratives#

N

Patient 1

SINCE THE DEVICE WAS NOT RETURNED, WE ARE UNABLE TO PERFORM FURTHER ROOT CAUSE ANALYSIS AND THE EXACT CAUSE OF THE REPORTED EVENT IS UNKNOWN. ALL DEVICES ARE 100% TESTED AND ALL PRODUCTS ARE 100% INSPECTED FOR DAMAGES AND IRREGULARITIES DURING MANUFACTURE. NO CORRECTIVE ACTION. MONITORING AND TRENDING THIS TYPE OF EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

D

Patient 1

MEDTRONIC RECEIVED REPORT THAT THE PIPELINE FLEX WITH SHIELD DEVICE DID NOT OPEN AT THE PROXIMAL SECTION. THE HYPERGLIDE BALLOON WAS SELECTED TO OPEN THE PIPELINE DEVICE. HOWEVER, THE BALLOON RUPTURED DURING THE INFLATION. A NEW BALLOON WAS USED TO OPEN THE PIPELINE DEVICE. NO PATIENT INJURY OCCURRED. THE VESSEL ANATOMY WAS NORMAL IN TORTUOSITY. THE PIPELINE WAS PLACE IN A CURB / BEND IN THE ANATOMY.