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

Model Number UNKNOWN

Device Problem Contamination (1120)

Patient Problems Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Cardiac Perforation (2513)

Event Date 11/21/2016

Event Type  Injury  

Event Description

This procedure was to extract 3 cardiac leads due to cied system/pocket infection.The leads were prepped with spectranetics lead locking devices.During extraction of the ra lead the patient experienced a drop in blood pressure.A tear in the ra was noted and repaired via sternotomy.The patient survived the procedure and intervention.This report is being made against the lld as it was the traction platform for the ra lead.

• 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: tresa osborne ; 9965 federal dr.; colorado springs, CO 80921 ; 719447-225
• MDR Report Key: 6175855
• MDR Text Key: 62536570
• Report Number: 1721279-2016-00191
• 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
• Report Date: 11/21/2016

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: 11/21/2016
• Initial Date FDA Received: 12/15/2016
• 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 1056T (IMPL. 132 MOS); CARDIAC LEAD, SJM 1642T (IMPL.72 MOS); CARDIAC LEAD, SJM 7120 (IMPL.132 MOS); GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 LASER SYSTEM
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 61 YR
• Patient Weight: 98