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

Model Number 518-062

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/07/2023

Event Type  Injury  

Event Description

A lead extraction procedure commenced to remove a right atrial (ra), a left ventricular (lv), and two right ventricular (rv) leads due to cied system/pocket infection.The rv lead, implanted in 2022, pulled out with simple traction (no traction platform utilized).Then, spectranetics lld ez lead locking devices (lld ez) were inserted into the remaining 3 leads to provide traction.Beginning with a spectranetics 12f glidelight laser sheath and a spectranetics visisheath dilator sheath, and alternating between the ra and lv leads, advancement could not be gained past the subclavian vein.Upsizing to a 14f glidelight and working to remove the rv lead, progress stalled in the same region.A spectranetics 13f tightrail sub-c rotating dilator sheath was used next, with no advancement.At that time, the decision was made to abandon the lead extraction.The physician did not attempt to unlock the lld ezs from the leads.The ra lead/lld (mdr #3007284006-2023-00077), the rv lead/lld (mdr #3007284006-2023-00078), and the lv lead/lld (mdr #3007284006-2023-00079) were cut and capped and remained in the patient.The patient survived the procedure.This report captures the lld within the rv lead which was cut and capped and remained in the patient.

Manufacturer Narrative

A4): patient's weight unk.B6): relevant tests/laboratory data unk.B7): other relevant history unk.H3): a portion of the device was discarded, and a portion remained in the patient, thus no investigation could be completed.H6): although lld cut/cap is a known risk of complication with use of the lld, the physician did not attempt to unlock the lld from the rv lead prior to cutting and capping.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.

• Brand Name: LLD EZ LEAD LOCKING DEVICE
• Type of Device: STYLET, CATHETER
• Manufacturer (Section D): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 18248408
• MDR Text Key: 329553498
• Report Number: 3007284006-2023-00078
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 20813132023076
• UDI-Public: (01)20813132023076(17)250412(10)FLP23D06A
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP23D06A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2023
• 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: ABBOTT LDA21Q RV ICD LEAD; BIOTRONIK COROX OTW-S LV LEAD; BIOTRONIK LINOX D 60 RV ICD LEAD; BIOTRONIK SETROX RA PACING LEAD; SPECTRANETICS 12F GLIDELIGHT LASER SHEATH; SPECTRANETICS 13F TIGHTRAIL SUB-C DILATOR SHEATH; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LLD EZ LEAD LOCKING DEVICES; SPECTRANETICS VISISHEATH DILATOR SHEATH
• Patient Outcome(s): Other
• Patient Age: 86 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American