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

Model Number 518-019

Device Problem Failure to Advance (2524)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/04/2014

Event Type  malfunction  

Event Description

Lead management case to extract two leads due to cied system infection.The physician was unable to get through a difficult occlusion with a glidelight laser sheath and made the decision to abandon the case.In abandoning the case the physician cut and capped an lld #2 and an lld ez.An mdr report will be made for each lld abandoned.

Manufacturer Narrative

The other lld ez will be reported under mdr 1721279-2014-00099.

Manufacturer Narrative

This follow up report is to provide additional patient details (patient weight, medical history, pre-op labs/tests).

• 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: 3887196
• MDR Text Key: 4539769
• Report Number: 1721279-2014-00098
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P043401
• 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,Followup
• Report Date: 06/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: M204518019188010215FLC13B13A86
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/09/2014
• 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: SPECTRANETICS LEAD LOCKING DEVICE EZ; SPECTRANETICS GLIDELIGHT LASER SHEATH; SJM 1342T PASSIVE PLUS CARDIAC LEAD (IMPL. 120MO); SJM 1346T PASSIVE PLUS CARDIAC LEAD (IMPL. 120MO); SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
• Patient Outcome(s): Other
• Patient Age: 58 YR
• Patient Weight: 65