SPNC LASER SHEATH/LEAD LOCKING DEVICE

Report

Report Number: 1721279-2010-00007
Event Type: Injury
Date Received: March 9, 2010
Date of Event: February 16, 2010
Report Date: March 9, 2010
Manufacturer: SPECTRANETICS CORP.
Product Code: MFA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MN, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

ANALYSIS: THE DEVICES WERE DISPOSED OF DURING THE CODE AND WERE NOT RETURNED FOR ANALYSIS. THERE WERE NO ALLEGED DEFECTS OR NON-CONFORMANCES OF THE SPNC DEVICES. PATIENT OUTCOME: PATIENT RECOVERED AND WAS DISCHARGED WITH NO REPORTED DEFICITS. MANUFACTURER DATES FOR ALL DEVICES: UNKNOWN.

Description of Event or Problem · 1

INDICATION FOR PROCEDURE: ENDOCARDITIS. PROCEDURE: THIS WAS A BILATERAL APPROACH PERFORMED IN THE OPERATING ROOM TO EXTRACT 4 PACEMAKER LEADS. MD ATTACHED THE LLD-EZ TO THE DISTAL END OF THE LEAD AND BEGAN LASING WITH THE 12F SLS. MD NOTICED THE LASER WAS TRACKING THE LEAD BUT THEN HEADED OUTSIDE OF TRICUSPID IMPLANT. PATIENT'S PACEMAKER LEAD WAS IMPLANTED IN 1984 AND THE TRICUSPID VALVE IN THE MID 1990'S. THE IMPLANTING MD CAPTURED THE LEAD BETWEEN THE TRICUSPID RING AND LATERAL HEART WALL. ALL LEFT-SIDED LEADS WERE REMOVED SUCCESSFULLY, BUT ULTIMATELY THE 12F SLS BECAME LODGED IN THE PATIENT'S BODY AND MD WAS UNABLE TO REMOVE THE SLS. IT WAS DECIDED TO LEAVE THE SLS IN THE PT AND WOULD BE SCHEDULED FOR AN OPEN CHEST PROCEDURE THE FOLLOWING MORNING. CT SURGEON OPENED THE PT'S CHEST THE NEXT DAY, SUCCESSFULLY REMOVED THE LEAD AND THE SLS. MD DETERMINED THE LEAD'S INSULATION WAS COMPROMISED AND BUNCHED UP INSIDE THE LASER MAKING IT IMPOSSIBLE TO REMOVE THE SLS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SPNC LASER SHEATH/LEAD LOCKING DEVICE	12F SLS / LLD-EZ	MFA	SPECTRANETICS CORP.	500-001/518-062	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	74 YR		Required Intervention	GENERATION 4 EXCIMER LASER