FDA.reportPublic FDA data

MAUDE MDR 9580874

MDR report key
9580874
Report number
2024168-2020-00591
Event key
0
Event type
3
Date of event
2019-12-09
Date received
2020-01-13
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
MS. LINDSEY BELL
Address
26531 YNEZ RD. TEMECULA CA 92591 US
Phone
951-951-9519
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1COPILOTACCESSORIESABBOTT VASCULARDTLUNKNOWN COPILOT BBCN R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-01-130

Event Narratives#

N

Patient 1

EXEMPTION NUMBER E2019001. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

D

Patient 1

IT WAS REPORTED THAT A COPILOT SEEMED TO HAVE A LEAK DURING PREP. ANOTHER COPILOT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.