FDA.reportPublic FDA data

MAUDE MDR 9677797

MDR report key
9677797
Report number
1721279-2020-00024
Event key
0
Event type
3
Date of event
2020-01-03
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
MRS. BARBARA CREEL
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 CORPORATIONMFA500-302500-302UNAVAILABLE FROM FACILITY N
101---

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-02-0601. D

Event Narratives#

N

Patient 1

PATIENT'S DATE OF BIRTH UNAVAILABLE. PATIENT'S WEIGHT UNAVAILABLE. DEVICE LOT NUMBER, EXPIRATION DATE UNAVAILABLE. DEVICE MANUFACTURE DATE UNAVAILABLE BECAUSE LOT NUMBER UNAVAILABLE.

D

Patient 1

A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE TWO LEADS: A RIGHT ATRIAL (RA) LEAD AND A RIGHT VENTRICULAR (RV) LEAD DUE TO THIS PATIENT NOT REQUIRING THE DEVICE/LEADS ANY LONGER, AND THE PATIENT REQUESTED EXTRACTION. THE PHYSICIAN NOTED THIS WAS A DIFFICULT CASE, WITH SIGNIFICANT CALCIUM AND SCAR TISSUE PRESENT ON THE LEADS. BEGINNING WITH A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH AND MEDIUM VISISHEATH, THE CASE PROCEEDED. DUE TO STALLED PROGRESS, THE PHYSICIAN USED AN 11F TIGHTRAIL SUB-C DEVICE, THEN BACK TO THE GLIDELIGHT DEVICE, THEN TO AN 11F TIGHTRAIL DEVICE. THE PHYSICIAN WENT BACK AND FORTH BETWEEN THE RA AND RV LEADS IN ORDER TO PROGRESS. IT WAS REPORTED THAT BOTH LEADS WERE EXTRACTED. HOWEVER, AT THE TIME THE RV LEAD WAS REMOVED AND THE GLIDELIGHT DEVICE WAS REMOVED ALONG WITH THE LEAD, THE PATIENT'S BLOOD PRESSURE DROPPED. RESCUE EFFORTS BEGAN IMMEDIATELY. HOWEVER, DURING RESCUE AND WHILE THE TEAM ATTEMPTED TO IDENTIFY THE ISSUE, THE PATIENT'S HEART STOPPED AND CPR BEGAN. OTHER RESCUE EFFORTS WERE THEN ATTEMPTED, BUT THE PATIENT WENT INTO VENTRICULAR FIBRILLATION (VF) AND DIED. THE CARDIOTHORACIC SURGEON ARRIVED AND A STERNOTOMY WAS NOT PERFORMED. HOWEVER, THE PHYSICIAN FEELS THERE WAS AN INJURY IN THE SUPERIOR VENA CAVA (SVC)