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

Model Number 518-062

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/06/2018

Event Type  malfunction  

• Brand Name: SPECTRANETICS LLD EZ LEAD LOCKING DEVICE
• Type of Device: LLD
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 7477130
• Report Number: 1721279-2018-00051
• Device Sequence Number: 1
• Product Code: DRB
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,04/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/04/2020
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP18A03A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 04/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/03/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 0
• Treatment: SPECTRANETICS CVX-300 EXCIMER LASER; SPECTRANETICS GLIDELIGHT LASER SHEATH; SPECTRANETICS TIGHTRAIL DILATOR SHEATH
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 87 YR
• Patient Weight: 125