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

Model Number 518-062

Device Problem Difficult to Insert (1316)

Patient Problem No Information (3190)

Event Date 05/05/2014

Event Type  Injury  

Event Description

During a lead extraction case, an lld was not able to be inserted fully into the targeted lead.A tightrail was used to successfully relieve binding sites in the subclavian, innominate, svc, svc/ra junction.Additional traction force was applied to the lead using the lld, and the lead began to unravel and separate 5cm distal to the most distal point where the tightrail was used.The lead separation occurred distal to the furthest point that the lld could be inserted.Prior damage to the lead was not able to be seen on fluoro prior to the procedure, however, it is believed that there was some pre-existing compromise to the lead's integrity that prevented the lld from being inserted all the way to the end of the lead.The physician believed that it was the compromise in the lead that caused it to separate and not the lld.Because of the potential for injury with recurrence and because the lld was used as a traction platform when the lead came apart, we are reporting this event.

• 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: 3822194
• MDR Text Key: 18063578
• Report Number: 1721279-2014-00077
• 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: 05/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2014
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2014
• 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 TIGHTRAIL ROTATING DILATOR SHEATH; BOSTON SCIENTIFIC ACUITY SPIRAL 4591 (IMPL 69 MON)
• Patient Outcome(s): Other
• Patient Age: 79 YR