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

Model Number 518-019

Device Problem Device Inoperable (1663)

Patient Problems Injury (2348); Foreign Body In Patient (2687)

Event Date 02/01/2018

Event Type  Injury  

Manufacturer Narrative

This event occurred during the same procedure, with the same patient as reported in mdr report #1721279-2018-00028.Device lot number and expiration date are not available from the facility.Device manufacture date is dependent on the device lot number, thus is unavailable.

Event Description

It was reported that during a lead extraction procedure to remove 4 non-functional cardiac leads (2 in rv, 2 in ra), a lead was cut and capped with an lld device within it.Reportedly, the left sided active icd lead was removed successfully and without complication.Next, the right-sided ra lead was to be removed.A complication occurred while removing an ra lead.The injury reportedly clotted by itself, and did not require repair.The remaining right chest leads were removed, but a lead in the left chest was cut and capped with an lld device within it.Patient outcome was good.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD
• Manufacturer (Section D): SPECTRANETICS; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS
• Manufacturer Contact: nick mcnabb ; 9965 federal drive; colorado springs, CO 80921 ; 719447-257
• MDR Report Key: 7294755
• MDR Text Key: 100889381
• Report Number: 1721279-2018-00029
• 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: 02/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 518-019
• Device Catalogue Number: 518-019
• Device Lot Number: UNAVAILABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2018
• 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?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 27 YR
• Patient Weight: 56