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

Model Number UNKNOWN

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Sepsis (2067); Injury (2348)

Event Date 10/24/2016

Event Type  Injury  

Event Description

This procedure was to extract two (2) cardiac leads from the rv, (mdt 6947 and sjm 7120 cut/capped lead) from a (b)(6) female due to sepsis.After the leads were prepped with spectranetics lead locking devices, the physician began with a spectranetics 14fr.Glidelight on the mdt lead and it was extracted in 19 seconds with no complications.The physician began removal of the sjm lead that had been previously cut/capped, stalled progression was encountered.The md up-sized to a 16fr.Glidelight and was able to reach the distal portion of the svc coil when hemodynamic changes were noted.There was an injury at the innominate/svc junction.The injury was repaired and the patient survived the procedure.Due to the patients comorbidities, the physician elected not to proceed with removal of the sjm lead that was previously abandoned, the lead was cut/capped with the lld inside.Evaluation of this patient is ongoing.This report is being made against the lld.Report against the glidelight in this case; 1721279-2016-00168.

• 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: sondra chandler ; 9965 federal dr; colorado springs, CO 80921 ; 719447-253
• MDR Report Key: 6114472
• MDR Text Key: 60427322
• Report Number: 1721279-2016-10169
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043401
• 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: 10/24/2016

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 Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/24/2016
• Initial Date FDA Received: 11/18/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/23/2017
• 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
• Treatment: CARDIAC LEAD MDT 6947 (IMPL. 38 MOS.); CARDIAC LEAD SJM 7120 (IMPL. 87 MOS.); SPECTRANETICS CVX-300 LASER SYSTEM; SPECTRANETICS GLIDELIGHT LASER SHEATH
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 42 YR
• Patient Weight: 132