FDA Adverse Event Injury Summary report: N

SPECTRANETICS LEAD LOCKING DEVICE

MDR report key: 3113763 · Received May 15, 2013

Report

Report Number
1721279-2013-00075
Event Type
Injury
Date Received
May 15, 2013
Date of Event
April 30, 2013
Report Date
April 30, 2013
Manufacturer
SPECTRANETICS CORPORATION
Product Code
DRB
PMA / PMN Number
K043401
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
IN, US
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

THIS WAS A LEAD EXTRACTION CASE TO REMOVAL ONE MDT 6949 LEAD. PHYSICIAN BEGAN WITH A 14F GLIDELIGHT AND VISISHEATH. THE PHYSICIAN MET VERY TOUGH BINDING AT THE PROXIMAL END OF THE SVC COIL AND COULD NOT ADVANCE THE VISISHEATH. THE 14F GLIDELIGHT WAS UPSIZED TO A 16F GLIDELIGHT, ALSO WITH A VISISHEATH, BUT MET THE SAME BARRIER. PHYSICIAN WAS USING HIGH FORCE TO TRY TO GET OVER THE BINDING SITE. A DROP IN BLOOD PRESSURE WAS NOTICED AND THE PHYSICIAN IDENTIFIED AN EFFUSION AT THE APEX. A PERICARDIOCENTESIS WAS PERFORMED AND 500CC OF BLOODY FLUID WAS REMOVED FROM THE PERICARDIAL SAC. CT SURGEON INTERVENED, CREATED A WINDOW, AND FOUND A SMALL SVC TEAR THAT HAD CLOTTED ITSELF OFF. THE CT THEN PERFORMED A STERNOTOMY AND IDENTIFIED A TEAR IN THE MID-SVC NEAR THE AZYGOS VEIN, WHICH WAS REPAIRED. THE LEAD WAS CAPPED AND ABANDONED INSIDE THE PATIENT. PATIENT IS CURRENTLY STABLE AND RESPONDING WITH POSITIVE HOPES FOR RECOVERY. PHYSICIAN FEELS HE CREATED THE HOLE WITH THE 14F GLIDELIGHT, AND THEN THE HOLE BECAME ENLARGED WITH THE 16F GLIDELIGHT, BASED ON CAPTURED REVIEW OF FLUORO.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
214160 SPECTRANETICS LEAD LOCKING DEVICE LLD-EZ DRB SPECTRANETICS CORPORATION 518-067 UNKNOWN

Patients

Seq Age Sex Outcome Treatment
1 52 YR Other 16F GLIDELIGHT| 14F GLIDELIGHT| CVX-300 EXCIMER LASER (SN (B)(4))| VISISHEATH, SIZE M