FDA.reportPublic FDA data

MAUDE MDR 9696002

MDR report key
9696002
Report number
1721279-2020-00032
Event key
0
Event type
3
Date of event
2020-01-15
Date received
2020-02-11
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 LEAD LOCKING DEVICELLDTHE SPECTRANETICS CORPORATIONDRBUNKNOWNUNAVAILABLE FROM FACILITY N
101---

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-02-1101. H; 2. L; 3. R

Event Narratives#

N

Patient 1

DEVICE MODEL NUMBER, LOT NUMBER, EXPIRATION DATE AND UDI UNAVAILABLE. 510K NUMBER UNAVAILABLE BECAUSE DEVICE MODEL NUMBER UNAVAILABLE. DEVICE MANUFACTURE DATE UNAVAILABLE BECAUSE LOT NUMBER UNAVAILABLE.

D

Patient 1

A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE THREE LEADS: A RIGHT ATRIAL (RA) LEAD, A RIGHT VENTRICULAR (RV) LEAD AND A LEFT VENTRICULAR (LV) LEAD DUE TO INFECTION. EACH LEAD WAS PREPPED WITH A SPECTRANETICS LEAD LOCKING DEVICE (LLD) TO PROVIDE TRACTION. THE PHYSICIAN BEGAN BY USING A 16F GLIDELIGHT LASER SHEATH AND SUCCESSFULLY EXTRACTED THE RV AND RA LEADS. THE TEAM PERFORMED A CORONARY SINUS (CS) VENOGRAM AND THEN PROCEEDED TO REMOVE THE LV LEAD USING 12F AND 16F GLIDELIGHT DEVICES. THE PROCEDURE WAS THEN COMPLETED, WITH THE PATIENT CLOSED AND EXTUBATED. HOWEVER, SHORTLY AFTERWARD, THE PATIENT'S HEART RATE DROPPED AND RESCUE EFFORTS COMMENCED IMMEDIATELY, INCLUDING CPR. THE PATIENT WAS RE-INTUBATED AND A PERICARDIOCENTESIS WAS PERFORMED, REMOVING A TOTAL OF 350CC FLUID. THE PATIENT SURVIVED THE PROCEDURE, AND WAS TRANSFERRED TO THE CARDIAC ICU. THE PATIENT'S CHEST WAS NEVER OPENED; THE PERICARDIOCENTESIS WAS THE ONLY INTERVENTION TO TREAT THE EFFUSION. THE PHYSICIAN BELIEVED THAT AS A RESULT OF TRACTION IN THE CORONARY SINUS, AN INJURY OCCURRED, LIKELY IN THE CORONARY SINUS. INJURY LOCATION WAS NEVER CONFIRMED.