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

Model Number 518-062

Device Problem Insufficient Information (3190)

Patient Problems Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930)

Event Date 11/05/2015

Event Type  Injury  

Event Description

Lead management case to extract one 6947 icd lead due to bacteremia.The patient presented to the case compromised and frail from the ongoing infection.The lead was prepped with an lld.The physician began the extraction using a 13fr tr in the subclavian.After releasing the binding sites in the subclavian the tr device was not used.The physician continued the extraction with traction only.After the lead was removed a drop in blood pressure was noted resulting in the discovery of an svc tear.The tear was repaired during a sternotomy.The patient survived the intervention.Physician comments that he does not believe an spnc device caused the injury and that the injury was due to the patient's vascular frailty presenting into the case.This adverse event is to report the lld as being a potential contributory device since it was the traction platform used in which to remove the lead.

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 EZ
• Manufacturer (Section D): SPECTRANETICS CORPORATION; 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: 5221248
• MDR Text Key: 31077697
• Report Number: 1721279-2015-00173
• 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: 11/10/2015

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 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: 11/10/2015
• Initial Date FDA Received: 11/12/2015
• Supplement Dates Manufacturer Received: Not provided; 08/17/2017
• Supplement Dates FDA Received: 03/22/2017; 08/23/2017
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 102