MAUDE Adverse Event Report: SPECTRANETICS CORPORTATION SPECTRANETICS LEAD LOCKING DEVICE; LLD #2

Model Number 518-019

Device Problem Positioning Problem (3009)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/12/2014

Event Type  malfunction  

Event Description

Lead management case to extract two abandoned leads implanted in 1990 (1012t ra and 1026t rv) and two active leads implanted in 1994 (1148t ra and 1226t rv).The locking stylet was not able to be fully inserted in the ra leads.The physician started with laser lead extraction to gain minimal vein access and then switched to tightrail using a technique in alternating between laser and tightrail as well as alternating leads the physician was able to make progress.As the case continued the physician began using the tightrail device more finally extracting 2 of the 4 leads (1026t and the 1148t).The physician attempted to use a cook eds system but decided to abandon the remainder of the leads due to the potential of them to fall apart; due to this issue 2 llds were abandoned.One lld is reported in adverse event report number 1721279-2014-00081 and one is reported in adverse event report number 1721279-2014-00082.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD #2
• 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: 3841666
• MDR Text Key: 17987962
• Report Number: 1721279-2014-00081
• 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: 05/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 02/07/2016
• Device Model Number: 518-019
• Device Catalogue Number: 518-019
• Device Lot Number: FLC14B07A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2014
• 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: SJM 1026T CARDIAC LEAD (IMPL. 1990); COOK EDS SYSTEM; SPECTRANETICS 12F GLIDELIGHT LASER SHEATH; SJM 1148T CARDIAC LEAD (IMPL. 1994); SPECTRANETICS LEAD LOCKING DEVICE #2 X3; SPECTRANETICS 11F TIGHTRAIL SHEATH; SJM 1226T CARDIAC LEAD (IMPL. 1994); SPECTRANETICS 33CM VISISHEATH X2; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SJM 1012T CARDIAC LEAD (IMPL. 1990)
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Weight: 92