GLIDELIGHT LASER SHEATH

MDR report key: 2736193 · Received September 7, 2012

Report

Report Number: 1721279-2012-00100
Event Type: Death
Date Received: September 7, 2012
Date of Event: July 25, 2012
Report Date: August 10, 2012
Manufacturer: SPECTRANETICS CORPORATION
Product Code: MFA
PMA / PMN Number: P960042
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: OH, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

DEVICE DISPOSED OF AFTER USE.

Description of Event or Problem · 1

A (B)(6) MALE WITH A FRACTURED MDT 6949 FIDELIS LEAD. MD WAS UNABLE TO GET A STYLET DOWN TO RETRACT THE SCREW, SO HE CUT THE LEAD AND TIED SEVERAL 0 ETHIBOND SUTURES AROUND THE LEAD AS A TRACTION PLATFORM. HE THEN USED A 14FR GLIDELIGHT TO REMOVE THE LEAD. LASING IN THE CLAVICLE "TOOK A LITTLE BIT LONGER THAN USUAL. PAST THE CLAVICLE THE LASER PROGRESSED SMOOTHLY AND LEAD FREED." MD DID NOT BLAME THE LASER SHEATH FOR THE PATIENT'S INJURY. THE INJURY TO THE SCV WAS NOT NOTED DURING THE PROCEDURE. THERE WAS A CONSIDERABLE AMOUNT OF BLOOD COMING FROM THE POCKET AND ONCE THE LEAD WAS REMOVED, THE PRESSURE DROPPED. IMMEDIATELY, BLOOD WAS GIVEN. THE CVS PERFORMED A PERICARDIAL WINDOW AND THERE WAS NO BLOOD IN THE HEART OR IN THE PERICARDIUM. THE PATIENT WAS PRONOUNCED DEAD AND THE PATIENT'S FAMILY DECLINED AN AUTOPSY. THE MD BELIEVES THERE WAS A SUBCLAVIAN TEAR AND DIDN'T REALIZE HOW MUCH BLOOD WAS LOST. HE ALSO BELIEVES THAT THE PATIENT HAD CAD THAT WAS UNDIAGNOSED SINCE HE WOULDN'T TEMPORARY PACE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	GLIDELIGHT LASER SHEATH	14F GL	MFA	SPECTRANETICS CORPORATION	500-302	UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1	66 YR		Death	MDT 6949 FIDELIS\| CVX-300 EXCIMER LASER