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

Model Number 518-062

Device Problem Positioning Problem (3009)

Patient Problems Low Blood Pressure/ Hypotension (1914); Scarring (2061); Pericardial Effusion (3271)

Event Date 04/09/2014

Event Type  Injury  

Event Description

Lead management case to extract a medtronic 4076 (impl.84 months) in the rv to upgrade to a biv icd device.The physician prepped the lead with an lld ez and began extracting using a 12f glidelight with a 33cm visisheath.An ice catheter was also placed in the groin to obtain a baseline visualization.Due to severe scarring the physician upsized to a 14f glidelight and the lead released.The physician noted that the blood pressure had dropped from 130/75 to 100/60 and a re-evaluation using the ice catheter revealed an effusion.A pericardiocentesis was performed removing 50cc of blood and resulting in overall dissipation of the effusion.The physician believed this injury was caused by the helix of the lead itself, believing it was affixed slightly outside the apex.Due to the type/likely location of the lead, the injury was most likely caused by the release of the lead in which the lld provided the traction platform for lead removal.The ra lead was not planned to be removed during this extraction and remained intact throughout the procedure.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE EZ
• Type of Device: LLD EZ
• Manufacturer (Section D): SPECTRANETICS CORPORTATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS CORPORTATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: sondra chandler rn ; 9965 federal drive; colorado springs, CO 80921 ; 7194472530
• MDR Report Key: 3749689
• MDR Text Key: 4484258
• Report Number: 1721279-2014-00057
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 11/06/2015
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP13L06A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/09/2014
• Initial Date FDA Received: 04/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2013
• 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 12F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS 33CM VISISHEATH; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; MEDTRONIC 4076 CAPSUREFIX NOVUS (IMPL. 2007 IN RA); MEDTRONIC 4076 CAPSUREFIX NOVUS (IMPL. 84MO IN RV)
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 79 YR
• Patient Weight: 75