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

Model Number 518-062

Device Problems Break (1069); Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/26/2017

Event Type  Injury  

Event Description

Lead management case to extract one non-functional 1580 icd lead.During the procedure the lead locking device broke in the lead.The remainder of the lead was able to be extracted and no harm came to the patient.No devices were left inside the patient.

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: jason hearn ; 9965 federal dr.; colorado springs, CO 80921 ; 719447-236
• MDR Report Key: 6323914
• MDR Text Key: 67210566
• Report Number: 1721279-2017-00021
• 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
• Report Date: 01/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/26/2017
• Initial Date FDA Received: 02/10/2017
• Supplement Dates Manufacturer Received: 07/24/2017
• Supplement Dates FDA Received: 08/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 1580 CARDIAC LEAD (IMPL 120MO); SPECTRANETICS TIGHTRAIL DILATOR SHEATH
• Patient Outcome(s): Other