MAUDE MDR 9869301

MDR report key
9869301
Report number
1721279-2020-00057
Event key
0
Event type
3
Date of event
2020-02-27
Date received
2020-03-23
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 16F GLIDELIGHT LASER SHEATHGLIDELIGHTTHE SPECTRANETICS CORPORATIONMFA500-303500-303FGC19M14A N
101---

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-2301. H; 2. L; 3. R

Event Narratives#

D

Patient 1

A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT ATRIUM (RA) AND A RIGHT VENTRICLE (RV) LEAD DUE TO CIED SYSTEM/POCKET INFECTION. THERE WERE MULTIPLE DEVICES USED BY THE PHYSICIAN TO AID IN THE REMOVAL OF THE LEADS. THE RV LEAD WAS EXTRACTED SUCCESSFULLY. DURING REMOVAL OF RA LEAD WITH THE SPECTRANETICS 16 FR GLIDELIGHT LASER SHEATH, THE PATIENT'S BLOOD PRESSURE DROPPED. FLUOROSCOPY SHOWED THAT THE RIGHT LUNG COLLAPSED AND HAD FILLED WITH BLOOD. RESCUE INTERVENTION COMMENCED IMMEDIATELY. A CHEST TUBE WAS PLACED ON THE PATIENT'' RIGHT SIDE AND A SMALL HOLE IN THE HEART WAS DETERMINED BY DIGITAL SUBTRACTION ANGIOGRAPHY (DSA). AFTER ABOUT TEN MINUTES, THE SMALL 3MM HOLE IN SVC HAD SEALED OFF BY COAGULATION OR CLOTTING. THE CHEST TUBE HAD AN OUTPUT OF 1600ML. PRESSURE NORMALIZED AND THE PATIENT'S REIMPLANTATION WAS SCHEDULED FOR THE FOLLOWING DAY. REIMPLANTATION WAS SUCCESSFUL AND THE PATIENT SURVIVED THE PROCEDURES. THERE WAS NO REPORTED MALFUNCTION OF THE SPECTRANETICS DEVICES.