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

Model Number 518-062

Device Problems Occlusion Within Device (1423); Sticking (1597); Device Inoperable (1663); Device Displays Incorrect Message (2591)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/16/2014

Event Type  Injury  

Event Description

This was a lead extraction case performed in the hybrid or to remove two non-functioning leads from the ra (mdt 5568 and 5076, implanted for 89 months).The first lead (mdt 5568) was successfully extracted with no issues.The second lead (mdt 5076) was prepped with an lld-ez and a laser catheter was used for the extraction.During the procedure, the laser gave a fault code, and stopped working.The manufacturer engineer was called and instructions were provided to try and reset the laser.After trying all possible remedies, and the laser not functioning, the physician determined the best method to treat the patient was to leave the remaining lead in place.There were no alternative means available for this physician to extract the lead.The patient had an occluded svc and the physician was unable to put in a new ra lead.The physician cut and capped the 5076 lead, leaving a part of the lld in the lead in the patient.

• 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: linda todd ; 9965 federal drive; colorado springs, CO 80921 ; 7194472567
• MDR Report Key: 4213762
• MDR Text Key: 18872130
• Report Number: 1721279-2014-00193
• 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: 10/16/2014

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: 02/20/2016
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP14B20A
• Other Device ID Number: M204518062058010216FLP14B20A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/16/2014
• Initial Date FDA Received: 10/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2014
• 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: CVX-300 EXCIMER LASER; VISISHEATH DILATOR SHEATH; GLIDELIGHT LASER SHEATH
• Patient Outcome(s): Other
• Patient Age: 69 YR