MAUDE Adverse Event Report: SPECTRANETICS CORPORATION LLD #1 LEAD LOCKING DEVICE; STYLET, CATHETER

Model Number	518-021
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B6): relevant tests/laboratory data 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 the lld, the physician did not attempt to unlock the lld from the ra 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.
Event or Problem Description
A lead extraction procedure commenced to remove a right atrial (ra) and two right ventricular (rv) leads (one active, one abandoned) due to cied system/pocket infection.Insertion of spectranetics lead locking devices (llds) were attempted in the abandoned and the active rv leads to provide traction, but could not be advanced farther than the middle of the leads, and were removed.An lld was successfully placed in the ra lead, and a spectranetics 9f tightrail sub-c rotating dilator sheath was used to remove adhesions in the subclavian region.A spectranetics 12f glidelight laser sheath was used next; however, progress stalled near the superior vena cava (svc) region due to calcium.An lld was then inserted in the active rv lead, which could only be advanced to the middle of the lead, and was locked in place.Using the same tightrail sub-c and glidelight devices, progress stalled in the svc region, same area where progress stalled on the ra lead.Due to heavy fibrosis/calcifications, the patient's advanced age, and that the extraction attempts continued for nearly 4 hours, it was determined there was no way to extract these leads.The physician did not attempt to unlock the llds from the leads prior to cutting and capping the ra lead (mdr #3007284006-2023-00010) and active rv lead (mdr #3007284006-2023-00009), which remained in the patient.A micra (leadless pacemaker) was implanted, and the patient survived the procedure.This report captures the lld within the ra lead which was cut and capped and remained in the patient.There was no alleged malfunction of any spectranetics devices in use during the procedure.
Additional Manufacturer Narrative
D1): brand name corrected to lld #1 lead locking device (from lead locking device) to align with brand name on the product label.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 #1 LEAD LOCKING DEVICE
• Common Device Name: 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 ; 719447-2465
• MDR Report Key: 17461330
• Report Number: 3007284006-2023-00010
• Device Sequence Number: 7236789
• Product Code: DRB
• UDI-Device Identifier: 00813132023003
• UDI-Public: (01)00813132023003(17)250501(10)FLB23D25A
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K990713
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/01/2025
• Device Model Number: 518-021
• Device Catalogue Number: 518-021
• Device Lot Number: FLB23D25A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/04/2023
• Supplement Report FDA Received Date: 08/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ABANDONED RV LEAD MANUFACTURER/TYPE/MODEL UNK; ACTIVE RA PACING LEAD MANUFACTURER/MODEL UNK; ACTIVE RV LEAD MANUFACTURER/TYPE/MODEL UNK; SPECTRANETICS 12F GLIDELIGHT LASER SHEATH; SPECTRANETICS 9F TIGHTRAIL SUB-C DILATOR SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LEAD LOCKING DEVICE IN RV LEAD
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White