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

Model Number 518-039

Device Problems Device Damaged by Another Device (2915); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/28/2024

Event Type  Injury  

Event Description

A lead extraction procedure commenced to remove a left ventricular (lv) lead due to non function.A right atrial (ra) and a right ventricular (rv) lead were present within the patient as well, but were not targeted for extraction.A spectranetics lld e lead locking device (lld e) was inserted into the lv lead to provide traction, but only advancing prior to the innominate/superior vena cava (svc) junction.Beginning with a spectranetics 14f glidelight laser sheath, the device could not get past the bend due to significantly tortuous anatomy.Entry into the pocket and subclavian vein was at a sharp upward angle, then the vessel turned downward approximately 100-110 degrees medially and towards the feet.Next, a spectranetics 11f tightrail sub-c rotating dilator sheath, followed by an 11f tightrail (long) were attempted.Neither device could navigate the extreme bend.The decision was made to switch back to the 14f glidelight with the glidelight teflon outer sheath.While attempting to make the glidelight bend with the anatomy, the lld e and lead broke.Due to the steep angle of the vessel, the physician believed that the tightrail devices significantly weakened/cut through the lv lead, ultimately causing the break.At that time, the lead extraction was aborted, and the lead/lld e were capped and remained in the patient.Plans were being made to bring the patient back at a later date to attempt implantation of a new lead.The patient survived the procedure.This report captures the lld within the lv lead which was capped and remained in the patient.There was no alleged malfunction of any spectranetics devices in use during the procedure.

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): per report, the device damage and lead/lld cap was related to patient condition (tortuous, steep angle of the vasculature).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 E 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: 19172654
• MDR Text Key: 340921064
• Report Number: 3007284006-2024-00082
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 20813132023058
• UDI-Public: (01)20813132023058(17)251024(10)FLJ23K19A
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043401
• 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: 04/24/2024

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: 518-039
• Device Catalogue Number: 518-039
• Device Lot Number: FLJ23K19A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2023
• 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 1458Q/86 LV LEAD; ABBOTT 2088TC/52 RA PACING LEAD; ABBOTT 7122Q/65 RV ICD LEAD; SPECTRANETICS 11F TIGHTRAIL DILATOR SHEATH; SPECTRANETICS 11F TIGHTRAIL SUB-C DILATOR SHEATH; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White