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

Model Number 518-062

Device Problem Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/27/2017

Event Type  Injury  

Manufacturer Narrative

Device expiration date unavailable from facility.Device manufacture date unavailable from facility.

Event Description

During a lead extraction procedure, the atrial lead would not pass through the svc during the removal attempt.The physician made the decision to cut, cap and abandon the lead in the pocket within the patient.The lld was left in the lead.

• 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: 6801120
• MDR Text Key: 82931937
• Report Number: 1721279-2017-00167
• 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: 07/27/2017

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 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
• Date Manufacturer Received: 07/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNAVAILABLE FROM FACILITY
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 68