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

Model Number 518-062

Device Problems Difficult to Remove (1528); Device Inoperable (1663)

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

Event Date 11/17/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

This case was to extract one cardiac lead from the rv due to a non-functional lead.The lead was prepped with a spectranetics lead locking device.Due to difficultly with the extraction, the physician decided to discontinue efforts.The spectranetics lead locking device was cut and capped and remains in the patient.The patient was otherwise stable after the procedure.

Manufacturer Narrative

Device 510k number has been corrected to reflect the most current and up to date number, as of the date of the initial report.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD
• Manufacturer (Section D): SPECTRANETICS; 9965 federal dr.; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 6159365
• MDR Text Key: 62099753
• Report Number: 1721279-2016-00189
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/17/2016

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: 06/30/2016
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP16F30A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/17/2016
• Initial Date FDA Received: 12/09/2016
• Supplement Dates Manufacturer Received: Not provided; 07/24/2017
• Supplement Dates FDA Received: 03/23/2017; 08/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2016
• 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 CVX-300 LASER SYSTEM
• Patient Outcome(s): Other
• Patient Age: 70 YR