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

Model Number 518-019

Device Problems Detachment Of Device Component (1104); Sticking (1597)

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

Event Date 10/15/2014

Event Type  Injury  

Event Description

This was a lead extraction case to remove one atrial lead (bs 4473), due to malfunction.The physician prepped lead using an lld # 2 with a 14 fr.Glidelight catheter.As the physician advanced catheter, the lead tip came free and pulled back, getting stuck on the proximal end of the proximal coil of the adjacent icd lead (bs 0174).The physician could feel the lead unraveling, and could not pull to maintain rail without impacting the rv lead.The physician decided to cut the atrial lead, leaving part of the lld retained in the ra lead.No injury to the patient occurred.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD #2
• 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: 4200119
• MDR Text Key: 18262358
• Report Number: 1721279-2014-00181
• 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: 10/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/13/2015
• Device Model Number: 518-019
• Device Catalogue Number: 518-019
• Device Lot Number: FLC13B13A
• Other Device ID Number: M204518019188010215FLC13B13A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2013
• 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: 14 F GLIDELIGHT; CVX-300 EXCIMER LASER; BS 0174 CARDIAC LEAD; BS 4473 CARDIAC LEAD
• Patient Outcome(s): Other
• Patient Age: 68 YR
• Patient Weight: 107