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

Model Number 518-062

Device Problems Fitting Problem (2183); Device Operates Differently Than Expected (2913)

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

Event Date 10/20/2014

Event Type  Injury  

Event Description

This was a left-sided lead extraction procedure to remove one 132 month old malfunctioning mdt 6947 rv icd lead.The plan was to extract the malfunctioning 6947 and place a new single coil icd lead and an intracardiac lv lead.The 6947 rv lead was prepped with an lld and a 16f glidelight was used for the extraction.After advancing the laser sheath past the icd lead's proximal coil and approaching the ivc, it was noted that the "heel" of the lead was still approximate to the ivc by fluoroscopy.The laser sheath was advanced to this segment and then a consistent drop in the patient's blood pressure was noted.After fluoroscopic evaluation and tee confirmation of an effusion, the surgeon was notified and rescue protocol was initiated.A sternotomy was performed and an injury in the ivc (junction of lower ra and ivc junction) was found and repaired.The icd lead was cut and capped with the lld still inside of the lead and an epicardial lead was placed by the surgeon.The patient will be further assessed for a new rv icd lead at a later date.This report captures the lld requiring situational abandonment within the lead.

• 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; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: jessica hearn bsn, rn ; 9965 federal drive; colorado springs, CO 80921 ; 7194472258
• MDR Report Key: 4243625
• MDR Text Key: 5046606
• Report Number: 1721279-2014-00197
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/20/2014

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 Model Number: 518-062
• Device Catalogue Number: 518-062
• Other Device ID Number: PARTIAL UDI: M20451806205
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/20/2014
• Initial Date FDA Received: 11/11/2014
• 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 16F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; MEDTRONIC 6947 SPRINT QUATTRO RV ICD (IMPL 132 MO)
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Weight: 110