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

Model Number 518-062

Device Problem Fracture (1260)

Patient Problem Foreign Body Sensation in Eye (1869)

Event Date 04/19/2017

Event Type  Injury  

Event Description

It was reported that during a lead extraction procedure to remove a fractured rv lead, the lead was prepped with a spectranetics lead locking device (lld) and a glidelight laser sheath was used to advance to within 1 inch of the tip of the lead.The lead was unable to be freed with traction force and the decision was made to abandon the lead.The lead was cut and capped along with the lld that was inside it.The patient was transferred to cicu and outcome was good.

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 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: 6559818
• MDR Text Key: 74935310
• Report Number: 1721279-2017-00082
• 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,Followup
• Report Date: 04/19/2017

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: 04/19/2017
• Initial Date FDA Received: 05/11/2017
• Supplement Dates Manufacturer Received: 07/24/2017
• Supplement Dates FDA Received: 08/04/2017
• 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
• Treatment: BOSTON SCIENTIFIC PACING LEAD 4136 (IMPL 45MO); BOSTON SCIENTIFIC PACING LEAD 4469 (IMPL 45MO); SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS GLIDELIGHT LASER SHEATH
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 85 YR