FDA.reportPublic FDA data

MAUDE MDR 9687454

MDR report key
9687454
Report number
1721279-2020-00028
Event key
0
Event type
3
Date of event
2020-01-10
Date received
2020-02-10
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 LEAD LOCKING DEVICELLDTHE SPECTRANETICS CORPORATIONDRB518-062518-062FLP19E01A N
101---

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-02-1001. H; 2. L; 3. R

Event Narratives#

N

Patient 1

DATE OF BIRTH UNKNOWN. WEIGHT UNKNOWN.

D

Patient 1

A LEAD EXTRACTION PROCEDURE COMMENCED FOR THE EXTRACTION OF A RIGHT VENTRICLE (RV) AND A RIGHT ATRIUM (RA) LEAD DUE TO INFECTION. THE RV AND RA WERE IMPLANTED IN 2006. SPECTRANETICS LEAD LOCKING DEVICES AND 14F GLIDELIGHT WERE BEING USED IN THE PROCEDURE. PROGRESS HAD STALLED ON BOTH OF THE LEAD ATTEMPTS IN THE AREA OF THE SUBCLAVIAN VEIN DUE TO ADHESION. THEY THEN USED A MECHANICAL DEVICE MANUFACTURED BY COOK, AND THE LEAD BEGAN TO STRETCH OUT. THEY REMOVED THE RA LEAD USING A SNARE (MANUFACTURER UNKNOWN) FROM THE FEMORAL ACCESS SITE. THEY THEN ATTEMPTED TO REMOVE THE RV LEAD ALSO USING THE SNARE AND LASING AT THE PROXIMAL END OF THE LEAD. IT WAS THEN THAT THEY NOTICED BLEEDING HAD INCREASED FROM THE POCKET AND A CAUTERY KNIFE WAS USED TO OBTAIN HEMOSTASIS IN THE AREA OF THE POCKET, BUT IT WAS NOT SUCCESSFUL. THEY THEN DISCOVERED THAT THERE WAS A TEAR IN SUBCLAVIAN VEIN AND RESCUE INTERVENTIONS COMMENCED. THEY REPAIRED THE INJURY TO THE SUBCLAVIAN BY SUTURING. AFTER THE REPAIR, THE PROCEDURE CONTINUED AND THEY REMOVED THE RV LEAD SUCCESSFULLY USING THE SNARE. PATIENT SURVIVED THE PROCEDURE. THE PHYSICIAN MENTIONED THAT FELT THIS EVENT OCCURRED DUE TO EITHER TOO MUCH TRACTION OR TOO MUCH PEELING USING THE CAUTERY KNIFE.