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

Model Number 518-067

Device Problem Material Separation (1562)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/28/2023

Event Type  Injury  

Manufacturer Narrative

A2): patient''s date of birth, age unk.A4): patient''s weight unk.H3): the device was not returned, thus no investigation could be completed.H6): device damage 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.

Event Description

A lead extraction procedure commenced to remove a right ventricular (rv), a right atrial (ra), and a left ventricular (lv) lead due to bacteremia and cied system/pocket infection.A spectranetics lld ez lead locking device (lld) was inserted into the rv lead to provide traction.However, at the beginning of the procedure and prior to use of any extraction tools, the patient''s heart stopped beating.Additionally, it was reported that the lld broke under the proximal buckle within the rv lead, cause unknown.There was no injury reported, but the patient''s hemodynamics were too unstable to continue the procedure.This report captures the lld ez present within the rv lead which broke, potential for harm with recurrence.

Manufacturer Narrative

H6: hecc code populated with 3165 (4582 no longer applicable).Heic code 2199 is no longer applicable.All other codes remain applicable as listed in the initial mdr.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or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.

Event Description

A lead extraction procedure commenced to remove a right ventricular (rv), a right atrial (ra), and a left ventricular (lv) lead due to bacteremia and cied system/pocket infection.A spectranetics lld ez lead locking device (lld) was inserted into the rv lead, and an lld (model unk) was inserted into the ra lead to provide traction.The lv lead was removed by simple traction, without use of a traction platform.However, prior to use of any extraction tools, the patient''s heart stopped beating.Afterwards, it was reported that a spectranetics glidelight laser sheath was used to aid in lead extraction.While attempting to remove the rv lead, the rv lead and lld broke (cause unk), in the area under the proximal buckle, and both were capped and remained in the patient (mdr 3007284006-2023-00023).The patient''s hemodynamics were too unstable to continue the procedure.Therefore, the ra lead was not removed; the physician did not attempt to unlock the lld from the ra lead prior to cutting and capping both, which remained in the patient (mdr #3007284006-2023-00027).This report captures the portion of the lld which was capped within the rv lead, and remained in the patient.

Manufacturer Narrative

D9): the device was returned to the manufacturer for evaluation 25oct2023.G3): the device evaluation and investigation was completed on 09nov2023.H3): the device was returned in multiple pieces.The proximal portion of the lld included the waveform, and the proximal piece of the core mandrel, which was looped and tangled at the waveform; therefore, accurate measurement could not be obtained.The middle portion, approximately 85 cm from the proximal end of the hypotube, included a piece of the core mandrel, hypotube and braid, with the core mandrel broken just distal to the waveform.At the distal end of this portion, the core mandrel and braid had been cut, with lead fragments present within the braid.The distal portion of the core mandrel and braid were not returned, aligning with the remnant of the lld that was cut and capped within the lead and remained in the patient.H6): based on the device evaluation and investigation, the cause of the lld damage could not be established.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: 17712489
• MDR Text Key: 322981798
• Report Number: 3007284006-2023-00023
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023065
• UDI-Public: (01)00813132023065(17)240422(10)FLK22D18A
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K142116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/22/2024
• Device Model Number: 518-067
• Device Catalogue Number: 518-067
• Device Lot Number: FLK22D18A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2022
• 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 CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS GLIDELIGHT LASER SHEATH; SPECTRANETICS LLD MODEL UNK IN RA LEAD; ST. JUDE MEDICAL DURATA RV ICD LEAD; ST. JUDE MEDICAL QUATTRO LV LEAD; ST. JUDE MEDICAL TENDRIL RA PACING LEAD
• Patient Outcome(s): Other
• Patient Sex: Male
• Patient Ethnicity: Hispanic
• Patient Race: White