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

Model Number 518-062

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 11/17/2017

Event Type  Injury  

Manufacturer Narrative

Device lot and expiration date unavailable.Device manufacture date unavailable.

Event Description

During a lead extraction procedure, a spectranetics lld ez device was in use with traction to remove the lead.During normal protocol of tee examination during the extraction it was noted that a slight effusion had formed.There was no reported malfunction with the lld.The patient survived the procedure and was closely monitored after the procedure; no additional intervention was required.

• Brand Name: SPECTRANETICS LLD 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: 7097400
• MDR Text Key: 94194532
• Report Number: 1721279-2017-00286
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K990713
• 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: 11/17/2017

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: UNAVAILABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/17/2017
• Initial Date FDA Received: 12/07/2017
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 52 YR
• Patient Weight: 84