MAUDE Adverse Event Report: SPECTRANETICS CORPORATION LLD #2 LEAD LOCKING DEVICE; STYLET, CATHETER

Model Number	518-019
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A2): patient''s date of birth unk.A4): patient''s weight unk.D4): device lot number, expiration date unk.Partial udi populated.H3): the device was discarded, thus no investigation could be complete.H4): device manufacture date unk because lot number unk.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 or Problem Description
A lead extraction procedure commenced to remove a right atrial (ra) and two right ventricular (rv) leads, one active and one capped, due to redundant lead.Spectranetics lld #2 lead locking devices (lld #2s) were inserted into each lead to provide traction.Multiple spectranetics devices (tightrail sub-c rotating dilator sheath, glidelight laser sheath) were used in the procedure.During the procedure, the active rv and ra leads were successfully removed.Then, using the tightrail sub-c on the capped rv lead, the lld and lead broke outside the patient''s body; therefore, there was no longer a traction platform.A snare was used from the groin, and the capped rv lead and lld remnants were successfully removed.The patient survived the procedure with no reported patient injury.This report captures the lld #2 providing traction within the capped rv lead which broke, requiring intervention.
Additional 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 #2 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: 18645159
• Report Number: 3007284006-2024-00028
• Device Sequence Number: 7317428
• Product Code: DRB
• UDI-Device Identifier: 00813132023010
• UDI-Public: 00813132023010
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 518-019
• Device Catalogue Number: 518-019
• 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: 07/16/2024
• Initial Report FDA Received Date: 02/05/2024
• Supplement Report FDA Received Date: 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: ABBOTT 7122Q ACTIVE RV PACING LEAD.; BOSTON SCIENTIFIC 7740 RA PACING LEAD.; BOSTON SCIENTIFIC 7741 CAPPED RV PACING LEAD.; SNARE MANUFACTURER/TYPE UNK.; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM.; SPECTRANETICS GLIDELIGHT LASER SHEATH.; SPECTRANETICS LLD #2 LEAD LOCKING DEVICES.; SPECTRANETICS TIGHTRAIL SUB-C DILATOR SHEATH.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White