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

Model Number 518-062

Device Problem Occlusion Within Device (1423)

Patient Problems Calcium Deposits/Calcification (1758); Perforation (2001)

Event Date 07/26/2016

Event Type  Injury  

Event Description

Procedure to extract two leads, ra and rv due to cied/system/pocket infection.The leads were both prepped with lld''s.The physician was moving the glidelight laser sheath over the ra lead, a second pass, attempting to move past an area of obstruction.The laser was not activated; however a perforation in the posterior aspect of the svc occurred.The injury was surgically repaired.The md stated that no further extraction could be performed due to severe calcification to the point of occlusion at the ra/svc jxn.The two llds were cut at the point they entered the leads and capped.The patient survived the procedure.The mdr for the glidelight; 1721279-2016-00101; 2nd lld;1721279-2016-00104.

Manufacturer Narrative

Device 510k number has been corrected to reflect the most current and up to date number, as of the date of the initial report.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD
• Manufacturer (Section D): SPECTRANETICS; 9965 federal dr.; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS
• Manufacturer Contact: nick mcnabb ; 9965 federal drive; colorado springs, CO 80921 ; 719447-257
• MDR Report Key: 5889773
• MDR Text Key: 53669451
• Report Number: 1721279-2016-00103
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2017
• 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
• Patient Outcome(s): Other
• Patient Age: 55 YR
• Patient Weight: 105