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

Model Number 518-018

Device Problem Break (1069)

Patient Problems Scarring (2061); Device Embedded In Tissue or Plaque (3165)

Event Date 02/08/2017

Event Type  Injury  

Event Description

It was reported that during a lead extraction procedure for a non-functional implantable cardioverter defibrillator (icd) lead, a portion of the spectranetics lead locking device (lld) was left inside the patient.Reportedly, scarring was encountered the entire length of the implanted lead, which led to breakage of the lead at the proximal shocking coil along with the proximal portion of the lld.The portion of the lead and the lld were abandoned and remain in the patient anatomy.No adverse affect on the patient was reported, and the patient was discharged per the operative plan.

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: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 6380122
• MDR Text Key: 69147222
• Report Number: 1721279-2017-00035
• 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
• Report Date: 02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 518-018
• Device Catalogue Number: 518-018
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2017
• 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 #0185 ICD LEAD (IMPL. 132MO); MEDTRONIC LEAD #6932 IN RV (IMPL. 228MO); MEDTRONIC LEAD #6943 IN RV (IMPL. 180MO); SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS GLIDELIGHT LASER SHEATH; SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH; SPECTRANETICS VISISHEATH DILATOR SHEATH
• Patient Outcome(s): Life Threatening
• Patient Age: 51 YR