FDA.reportPublic FDA data

MAUDE MDR 9676657

MDR report key
9676657
Report number
1721279-2020-00027
Event key
0
Event type
3
Date of event
2020-01-09
Date received
2020-02-06
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. NICOLE WORFORD
Address
9965 FEDERAL DRIVE COLORADO SPRINGS CO 80921 US
Phone
719-719-7194
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SPECTRANETICS 14F GLIDELIGHT LASER SHEATHGLIDELIGHTTHE SPECTRANETICS CORPORATIONMFA500-302500-302FGB19D12A N
101---

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-02-0601. H; 2. L; 3. R

Event Narratives#

D

Patient 1

A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE LEADS IN THE RIGHT VENTRICLE (RV), RIGHT ATRIUM (RA), AND 2 IN THE LEFT VENTRICLE (LV), DUE TO BACTEREMIA. THE RV, RA, AND ONE LV LEAD WERE EXTRACTED SUCCESSFULLY. THE LAST LV LEAD WAS BEING EXTRACTED WITH A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; HOWEVER IT WAS REPORTED THAT IT WAS DIFFICULT TO FOLLOW THE PATH OF THE LEAD, BUT STILL REMOVED SUCCESSFULLY AND SUBSEQUENT TO THE EXTRACTION OF ALL THE LEADS, A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS PERFORMED. THE TEE SHOWED AN EFFUSION AND THEN THE PATIENTS BLOOD PRESSURE DROPPED. RESCUE INTERVENTION COMMENCED AND A PERICARDIOCENTESIS WAS PERFORMED WITH NO SUCCESS. IT WAS THEN THAT THEY PERFORMED A STERNOTOMY IN ORDER TO FIND OUT WHERE THE BLEEDING WAS COMING FROM. IT WAS DISCOVERED THAT THERE WAS A TEAR IN THE CORONARY SINUS AND IT WAS REPAIRED SUCCESSFULLY. THE PATIENT RECEIVED 4 UNITS OF BLOOD DURING THE PROCEDURE. THE PATIENT SURVIVED THE PROCEDURE.