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

Model Number 518-062

Device Problems Fracture (1260); Difficult to Remove (1528)

Patient Problem No Information (3190)

Event Date 07/25/2017

Event Type  Injury  

Event Description

Lead extraction procedure to remove an icd lead due to lead fracture.Physician utilized an lld ez and attempted to remove the lead with use of glidelight 14fr & glidelight 16fr laser sheaths.Physician was able to get past occlusion and place a wire for new lead placement but could not extract the icd lead.At that time physician decided to abandon the lead extraction and cap the icd lead.Lead was cut and capped and left inside the patient with a portion of the lld still inside the lead.

• Brand Name: SPECTRANETICS LLZ EZ LEAD LOCKING DEVICE
• Type of Device: LLD
• Manufacturer (Section D): SPECTRANETICS; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 6801127
• MDR Text Key: 82930969
• Report Number: 1721279-2017-00166
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 05/05/2019
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP17E03A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2017
• 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: SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 81 YR
• Patient Weight: 64