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

Model Number 518-062

Device Problem Occlusion Within Device (1423)

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

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 lld #2 will be reported under mdr 1721279-2014-00098.

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 EZ
• 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: 3887201
• MDR Text Key: 4540267
• Report Number: 1721279-2014-00099
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 11/28/2014
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP12L28A
• Other Device ID Number: M204518062168011214FLP12L28A6W
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/09/2014
• Initial Date FDA Received: 06/20/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2012
• 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: SJM 1342T PASSIVE PLUS CARDIAC LEAD (IMPL. 120MO); SPECTRANETICS GLIDELIGHT LASER SHEATH; SJM 1346T PASSIVE PLUS CARDIAC LEAD (IMPL. 120MO); SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LEAD LOCKING DEVICE #2
• Patient Outcome(s): Other
• Patient Age: 58 YR
• Patient Weight: 65