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

Model Number 518-062

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/17/2024

Event Type  Injury  

Event Description

A lead extraction procedure commenced to remove a right atrial (ra), a right ventricular (rv) and a left ventricular (lv) lead due to non-function.Spectranetics lld ez lead locking devices (lld ezs) were inserted into each lead to provide traction.Beginning with a spectranetics 14f glidelight laser sheath with a medium visisheath dilator sheath on the ra lead, progress stalled due to lead on lead binding.Moving to the lv lead with the same glidelight, the lead was successfully removed.Moving again to the ra lead using the glidelight and visisheath, the remaining lead on lead binding was resolved in the innominate and superior vena cava (svc) regions.While the glidelight and visisheath were still located in the innominate/svc region, the ra lead came free and was removed, along with the glidelight and visisheath; however, the patient's blood pressure dropped.Rescue efforts began, including rescue balloon and sternotomy.A right atrial appendage (raa) perforation was discovered, clamped, and repaired (mdr #3007284006-2024-00030).Once the patient stabilized, it was decided to abandon extraction of the rv lead.Attempts were made to unlock the lld ez from the rv lead were unsuccessful; therefore, the rv lead/lld were cut and capped and remained in the patient (mdr).T he patient survived the procedure.This report captures the lld ez within the rv lead which was cut and capped and remained in the patient.

Manufacturer Narrative

Patient's date of birth unk other relevant history unk device lot number, expiration date unk.Partial udi populated.A portion of the device was discarded and a portion remained in the patient, thus no investigation could be completed.Device manufacture date unk because lot number unk.Lld cut and cap is a known risk of complication with use of the lld.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.

Manufacturer Narrative

D4: correction: removing primary di number from udi# field.The lot number was not provided, thus an entire udi# is unavailable.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: 18647393
• MDR Text Key: 334614627
• Report Number: 3007284006-2024-00031
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023072
• UDI-Public: 00813132023072
• 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,Followup
• Report Date: 07/24/2024

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: Health Professional
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/05/2024
• Supplement Dates Manufacturer Received: 07/16/2024
• Supplement Dates FDA Received: 07/24/2024
• 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: MEDTRONIC 4194 LV LEAD.; MEDTRONIC 5944 RA PACING LEAD.; MEDTRONIC 6944 RV PACING LEAD.; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH.; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM.; SPECTRANETICS LLD EZ IN RA LEAD.; SPECTRANETICS MEDIUM VISISHEATH DILATOR SHEATH.
• Patient Outcome(s): Other
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White