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

Model Number 518-019

Device Problems Break (1069); Difficult to Advance (2920)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/16/2014

Event Type  malfunction  

Event Description

This was a lead extraction case performed in the or to remove one lead from the rv (bsc icd lead, model 0174, implanted (b)(6) 2008).The physician prepped the lead with an lld # 2 and used a 14 fr glidelight laser catheter.The physician made progress with 14 fr.Laser to about the mid-proximal coil.The physician could not advance any further, so upsized to a 16 fr.Laser catheter.Physician will typically wrap the lld around his hand and grip it within his fist.He typically does not pull very hard but hard enough to get a good rail.Physician said he was not pulling harder than normal.He made small progress with the 16 fr.Catheter when the lld broke in the pocket away from where he was pulling traction.The lead also broke.The physician attempted to remove the remaining portion of the lead and lld with femoral tools.Unfortunately, not all was able to be removed; some part of the lead and lld remained near the innominate area.Patient is scheduled for open heart surgery on thursday (b)(6) to remove the remaining portion of lead and lld as the lead was being removed for endocarditis involving lead which also had large vegetation involving the icd lead crossing the tricuspid valve resulting in moderate tricuspid valve regurgitation.

• 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: 4200136
• MDR Text Key: 4962099
• Report Number: 1721279-2014-00182
• 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: 10/17/2014

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: 11/27/2014
• Device Model Number: 518-019
• Device Catalogue Number: 518-019
• Device Lot Number: FLC12L27A
• Other Device ID Number: M204518019188011114FLC12L27A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/17/2014
• Initial Date FDA Received: 10/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/27/2012
• 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: 16F GLIDELIGHT CATHETER; BSC 0174 CARDIAC LEAD; 14F GLIDELIGHT CATHETER; CVX-300 EXCIMER LASER
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 37 YR
• Patient Weight: 37