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

Model Number 518-062

Device Problem Human-Device Interface Problem (2949)

Patient Problems Low Blood Pressure/ Hypotension (1914); Cardiac Perforation (2513); Device Embedded In Tissue or Plaque (3165)

Event Date 12/11/2015

Event Type  Injury  

Event Description

Lead management case to extract 4 non-functional 5076 cardiac leads (two capped).The physician was able to successfully extract both ra and rv leads on the right side using a 12f glidelight and lld ez locking stylets.The left sided ra and rv leads were accessed and prepped with lld ez locking stylets and a 14f glidelight was started down the leads.The physician encountered heavy scarring on each lead.While on the ra lead the laser progressed into the svc/ra junction.The lead released from the myocardium and the patient became hypotensive.The patient was transferred to the cardiac or and small hole in the svc/ra junction was repaired.The patient survived the intervention; however the lld ez in the rv lead was cut/capped inside the patient.This report is to reflect on the cut/capped lld.For the glidelight that was used when the injury occurred see mdr 1721279-2015-00198.

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 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: 5338459
• MDR Text Key: 35259659
• Report Number: 1721279-2015-00199
• 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: 12/11/2015

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: 12/11/2015
• Initial Date FDA Received: 12/31/2015
• Supplement Dates Manufacturer Received: Not provided; 08/17/2017
• Supplement Dates FDA Received: 03/20/2017; 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: 68 YR
• Patient Weight: 68