FDA Adverse Event Injury Summary report: N

SPECTRANETICS LEAD LOCKING DEVICE

MDR report key: 3092721 · Received May 3, 2013

Report

Report Number
1721279-2013-00063
Event Type
Injury
Date Received
May 3, 2013
Date of Event
April 26, 2013
Report Date
April 26, 2013
Manufacturer
SPECTRANETICS CORPORATION
Product Code
DRB
PMA / PMN Number
K043401
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
MD, US
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

THIS WAS A LEAD EXTRACTION CASE PERFORMED IN THE OPERATING ROOM TO REMOVE ONE SJM RIATA (B)(4), DUAL COIL LEAD, DUE TO IT MALFUNCTIONING WITH OCCLUSION. THE LEAD WAS PREPPED WITH AN LLD EZ, AND THE PHYSICIAN STARTED WITH A 14F GLIDELIGHT LASER CATHETER. HE WAS ABLE TO ADVANCE THE LASER TO THE INITIAL PART OF THE PROXIMAL COIL, NO FURTHER, SO HE UPSIZE TO THE 16F GLIDELIGHT CATHETER. HE ADVANCED SLOWLY WITH THE BEVEL IN THE APPROPRIATE DIRECTION TO THE END OF THE PROXIMAL COIL. WHILE CONTINUING TO ADVANCE BETWEEN THE COILS, A BLOOD PRESSURE DROP WAS IDENTIFIED. THE SURGEON WAS IN THE ROOM, BUT THE TEE COULD NOT IDENTIFY AN EFFUSION AT THIS POINT. AFTER 2 MINUTES, IT WAS DECIDED TO HAVE THE SURGEON INTERVENE. AN EFFUSION WAS IDENTIFIED VIA TEE SHORTLY THEREAFTER, AND THEN A TAMPONADE WAS SEEN. THE PATIENT'S CHEST WAS OPENED AND THE BLOOD PRESSURE CONTINUED TO DROP. THE SURGEON IDENTIFIED THE INJURY ON THE LATERAL WALL OF THE SVC AND IT EXTENDED INTO THE RA. THE PATIENT WAS PLACED ON BYPASS AND THE INJURY WAS REPAIRED. THE PATIENT WAS STABLE ON THE PUMP. THE SURGEON ATTEMPTED TO UNLOCK THE LLD EZ FROM THE LEAD, BUT THIS ATTEMPT WAS UNSUCCESSFUL. THE LLD EZ WAS CUT AND THE LEAD WAS CAPPED AND ABANDONED. THE PATIENT WAS WEANED FROM BYPASS AND SENT TO THE ICU FOR RECOVERY.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
194197 SPECTRANETICS LEAD LOCKING DEVICE LLD-EZ DRB SPECTRANETICS CORPORATION 518-062 FLP12L07A

Patients

Seq Age Sex Outcome Treatment
1 45 YR Other SJM 1581 RIATA LEAD| 14F GLIDELIGHT| CVX-300 EXCIMER LASER (SN (B)(4))| 16F GLIDELIGHT