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

Model Number 518-019

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/10/2015

Event Type  Injury  

Event Description

This was a left sided lead extraction to remove 3 non-functional leads.All three leads were prepped with lead locking devices (lld).The physician elected to abandon the extraction because of the inability to extract the leads with the glidelight laser sheath and mechanical tool (cook evolution).One lld was removed successfully from the lead.The physician elected to cut and cap the other two leads with the llds still inside.The patient was discharged per operative plan and did not experience any ill effects from the procedure.The physician stated that the llds performed as intended and no malfunction occurred.

Manufacturer Narrative

(b)(4).

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD #2
• Manufacturer (Section D): SPECTRANETICS; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS
• Manufacturer Contact: sondra chandler ; 9965 federal dr; colorado springs, CO 80921 ; 7194472210
• MDR Report Key: 4863902
• MDR Text Key: 20367418
• Report Number: 1721279-2015-00099
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K043401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/10/2015

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: 03/03/2017
• Device Model Number: 518-019
• Device Catalogue Number: 518-019
• Device Lot Number: FLC15C03A
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/10/2015
• Initial Date FDA Received: 06/23/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2015
• 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 RIATA RV LEAD DUAL COIL; SPECTRANETICS LEAD LOCKING DEVICE (LLD) X 2; SPECTRANETICS CVX 300 EXCIMER LASER SYSTEM; PACING RV LEAD (UNKNOWN MANUFACTURER); COOK EVOLUTION; DUAL COIL RV LEAD ICD (UNKNOWN MANUFACTURER)
• Patient Outcome(s): Other
• Patient Age: 55 YR