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

Model Number 518-062

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Unspecified Infection (1930); Injury (2348); Pericardial Effusion (3271)

Event Date 12/07/2016

Event Type  Injury  

Event Description

This procedure was to extract two cardiac leads due to cied system/pocket infection, indwelling for 123 months.The leads were prepped with spectranetics lead locking devices for traction.Upon removal of the rv lead a cardiac effusion was noted on tee.A sternotomy revealed a tear in the apex of the rv.The injury was repaired and the patient survived the procedure.This report is being made against the spectranetics lld as the traction platform.

Manufacturer Narrative

Follow up provided to supply partial udi, patient and device codes.

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: 6214720
• MDR Text Key: 63609322
• Report Number: 1721279-2016-00198
• 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: 12/07/2016

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: 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: 12/07/2016
• Initial Date FDA Received: 12/29/2016
• Supplement Dates Manufacturer Received: Not provided; 07/24/2017
• Supplement Dates FDA Received: 02/07/2017; 08/09/2017
• 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, SJM 1642T (IMPL 123 MOS); CARDIAC LEAD, SJM 1646T (IMPL 123 MOS); SPECTRANETICS CVX-300 LASER SYSTEM; SPECTRANETICS GLIDELIGHT LASER SHEATH; SPECTRANETICS LEAD LOCKING DEVICES; SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 57 YR
• Patient Weight: 107