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

Model Number 518-062

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/27/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

This was a procedure to treat the patient for cardiac stenosis of the proximal lad from a moderately calcified lesion.A spectranetics 1.4mm elca laser sheath was selected to perform the procedure.During the procedure the radiopaque marker on the elca device separated from the catheter and became lodged in the artery.Multiple attempts, utilizing multiple devices were unsuccessful in retrieval of the marker.The case was abandoned and the patient was transferred to the ccu.

Manufacturer Narrative

(b)(4).

Event Description

A (b)(6) female presents for extraction of a fractured cardiac icd lead from the right ventricle, indwell time was 132 months.The lead was prepped with a spectranetics lead locking device, a 14 fr.Spectranetics glidelight laser sheath was used to free up the lead to the midway point of the proximal icd coil, then progress stalled.The device was upsized to a 16 fr.Spectranetics glidelight laser sheath which moved easily over the proximal coil and the lead came free.The 16 fr.Glidelight never traveled past the svc/ra junction.After extraction of the lead, the patient experienced a drop in blood pressure.Tee verified an effusion; the surgeon was called in and intervention was initiated.A tear was identified at the rv apex.The defect was repaired and the patient survived the procedure.This report is being made against the lead locking device as the potential mechanism of injury.

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: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 5799544
• MDR Text Key: 49755272
• Report Number: 1721279-2016-00088
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/27/2016

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?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/25/2018
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP16A25A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/23/2016
• Initial Date FDA Received: 07/15/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; 07/24/2017
• Supplement Dates FDA Received: 07/22/2016; 03/23/2017; 08/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2016
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 52 YR