MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS LEAD LOCKING DEVICE; STYLET, CATHETER

Model Number 518-062

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/12/2021

Event Type  Injury  

Manufacturer Narrative

Patient's weight unk.Patient's ethnicity/race unk.Other relevant history unk.The device was discarded, thus no investigation could be completed.

Event Description

A lead extraction procedure commenced to remove a right atrial (ra) lead, a right ventricular (rv) lead, and a left ventricular (lv) lead due to bacteremia.A spectranetics lead locking device (lld) was inserted into each lead to provide traction to aid in extraction.The physician used a spectranetics 16f glidelight laser sheath and a spectranetics 13f tightrail rotating dilator sheath to attempt removal of the leads but was unsuccessful.During attempts to extract the leads, all three of the leads along with the llds broke under the clavicle near the pocket and were abandoned in the patient.It was reported that the physician struggled to get a co-axial plane while attempting removal of the lead and llds out of the surgical pocket.Due to the severe angle and calcification, it compromised the integrity of the llds causing them to shear off.There was no reported patient injury.This report is being submitted to capture the lld which was providing traction to the ra lead when the lld and lead broke and both remained in the patient.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: STYLET, CATHETER
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: nicole worford ; 9965 federal drive; colorado springs, CO 80921
• MDR Report Key: 12422459
• MDR Text Key: 269823901
• Report Number: 1721279-2021-00170
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): Y
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/21/2022
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP20B18A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2020
• 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: SPECTRANETICS 16F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LLDS IN RV AND LV LEADS; SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH; ST. JUDE MEDICAL 1156T LV LEAD; ST. JUDE MEDICAL 1888TC RA PACING LEAD; ST. JUDE MEDICAL 7120Q RV ICD LEAD
• Patient Outcome(s): Other
• Patient Age: 54 YR