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

Model Number 518-019

Device Problem Break (1069)

Patient Problems Unspecified Infection (1930); Foreign Body In Patient (2687)

Event Date 09/27/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

During a lead extraction case due to cied/system infection, a spectranetics lead locking device was cut and capped and remains in the patient.

Manufacturer Narrative

Device 510k number has been corrected to reflect the most current and up to date number, as of the date of the initial report.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD
• Manufacturer (Section D): SPECTRANETICS; 9965 federal dr.; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS
• Manufacturer Contact: nick mcnabb ; 9965 federal drive; colorado springs, CO 80921 ; 719447-257
• MDR Report Key: 6038197
• MDR Text Key: 57778016
• Report Number: 1721279-2016-00149
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/27/2016

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 Expiration Date: 03/15/2018
• Device Model Number: 518-019
• Device Catalogue Number: 518-019
• Device Lot Number: FLC16C15B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/27/2016
• Initial Date FDA Received: 10/18/2016
• Supplement Dates Manufacturer Received: Not provided; 07/24/2017
• Supplement Dates FDA Received: 03/23/2017; 08/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2016
• 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: CARDIAC LEAD BSC 0134-64 (IMPL. 204 MOS.); CARDIAC LEAD BSC 4439 (IMPL. 204 MOS.); CARDIAC LEAD MDT 4194 (IMPL. 96 MOS.); CARDIAC LEAD, MDT 3830 (IMPL. 120 MOS.); SPECTRANETICS CVX-300 LASER SYSTEM; SPECTRANETICS LASER SHEATH II
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 56 YR
• Patient Weight: 81