FDA Adverse Event Injury Summary report: N

EXCIMER LASER CORONARY ANGIOPLASTY CATHETER

MDR report key: 2140943 · Received June 21, 2011

Report

Report Number
1721279-2011-00036
Event Type
Injury
Date Received
June 21, 2011
Date of Event
June 1, 2011
Report Date
June 1, 2011
Manufacturer
SPECTRANETICS CORPORATION
Product Code
LPC
PMA / PMN Number
P910001
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
NY, US
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

THIS WAS A CARDIAC CATHETERIZATION PROCEDURE CONDUCTED IN THE CATH LAB. THE PHYSICIAN INSERTED A CHOICE PT GUIDEWIRE AND BEGAN LASING WITH AN ELCA 0.9 RX LASER CATHETER. THE PATIENT'S VESSEL ANATOMY WAS VERY TORTUOUS AND HIGHLY CALCIFIED. WHILE LASING IN THE LAD, THE PHYSICIAN NOTED A PERFORATION ON FLUOROSCOPY AND CHOSE TO REMOVE THE ELCA IN ORDER TO TREAT THE PERFORATION BY BALLOONING AND STENTING THE VESSEL. DURING THE REMOVAL OF THE LASER CATHETER, THE GUIDEWIRE WAS INADVERTENTLY PULLED BACK, LOSING PLACEMENT. THE PHYSICIAN ATTEMPTED TO REPOSITION THE GUIDEWIRE WITH NO SUCCESS AND DECIDED TO INSERT A NEW GUIDEWIRE. UPON REMOVAL, THE GUIDEWIRE SNAGGED THE PERFORATION AND INCREASED THE SIZE OF THE INJURY. THE CV SURGEON AND THE OPERATING ROOM CARDIAC TEAM WERE NOTIFIED. SEVERAL MORE UNSUCCESSFUL ATTEMPTS WERE MADE TO RE-ESTABLISH GUIDEWIRE ACCESS. THE PATIENT DEVELOPED A CARDIAC TAMPONADE, WAS TAKEN TO THE OPERATING ROOM, WENT INTO CARDIAC ARREST, BUT WAS RESUSCITATED AND ULTIMATELY SURVIVED THE PROCEDURE. THE PATIENT WAS TRANSFERRED IN CRITICAL CONDITION TO THE ICU FOR RECOVERY. THERE WERE NO DEVICES RETAINED FOR RETURN ENGINEERING ANALYSIS, AS THEY WERE DISPOSED OF DURING THE CODE. SEVERAL UNSUCCESSFUL ATTEMPTS WERE MADE TO GATHER FURTHER LOT INFORMATION.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 EXCIMER LASER CORONARY ANGIOPLASTY CATHETER ELCA 0.9 RX LPC SPECTRANETICS CORPORATION 110-003 UNKNOWN

Patients

Seq Age Sex Outcome Treatment
1 64 YR Life Threatening| R BOSTON SCIENTIFIC CHOICE PT GUIDEWIRE| CVX-300 EXCIMER LASER SYSTEM (SERIAL# (B)(4))