MAUDE Adverse Event Report: SPECTRANETICS CORPORATION SPECTRANETICS LEAD LOCKING DEVICE; LLD EZ

Model Number 518-062

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Low Blood Pressure/ Hypotension (1914); Laceration(s) (1946)

Event Date 01/07/2015

Event Type  Death  

Event Description

Lead management case to extract 2 leads due to cied system/pocket infection.The physician prepped both leads with lld ezs and began the extraction by removing the rv lead with a 14f glidelight.While attempting to extract the ra lead the lead partially broke; however the physician was able to continue the extraction.After the lead released from the cardiac wall the patient¿s blood pressure dropped.The surgeon performed a sternotomy and discovered a tear at the ivc/ra junction.The tear was repaired but the patient did not survive the intervention.This is being reported on the lld because it is of the physician¿s opinion that the injury was caused by the lead and the lld was used as the traction platform for lead removal.

Manufacturer Narrative

Placeholder.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD EZ
• Manufacturer (Section D): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS CORPORATION
• Manufacturer Contact: sondra chandler ; 9965 federal drive; colorado springs, CO 80921 ; 7194472530
• MDR Report Key: 4439444
• MDR Text Key: 5314483
• Report Number: 1721279-2015-00005
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P960042
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: UNKNOWN
• Other Device ID Number: M2045003030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SPECTRANETICS GLIDELIGHT LASER SHEATH; UNKNOWN CARDIAC LEAD (IMPL. 168MO)X2; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LEAD LOCKING DEVICE EZ
• Patient Outcome(s): Death
• Patient Age: 90 YR
• Patient Weight: 68