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

Model Number	518-018
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	06/26/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A4) patient weight - not available from facility.A5) patient ethnicity - not available from facility.B7) other relevant history - not available from facility.H3) the lld #1 was discarded, thus no returned product investigation was performed.H6) cardiac perforation is a known risk of complication with use of the lld device.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 two (one capped and one active) right ventricular (rv) and right atrial (ra) leads due to non-function and occlusion.Spectranetics lld #1 lead locking devices (lld #1s) were inserted into each lead to provide traction.Beginning with a spectranetics 11f tightrail rotating dilator sheath on the capped rv lead, the lead was removed successfully.Next, using the same 11f tightrail, the ra lead was removed; however, the patient¿s blood pressure dropped, and a pericardial effusion was detected.Rescue efforts began, including rescue balloon, pericardiocentesis, and sternotomy.A perforation in the ra was discovered and repaired.The remaining rv lead was removed post-sternotomy using a spectranetics 13f tightrail rotating dilator sheath, and the patient survived the procedure.This report captures the lld #1 device providing traction to the ra lead when the perforation occurred, requiring intervention.There was no alleged malfunction of any spectranetics devices in use during the procedure.

• 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: nicole worford ; 9965 federal drive; colorado springs, CO 80921 ; 719447-2465
• MDR Report Key: 22396507
• Report Number: 3007284006-2025-00127
• Device Sequence Number: 20975766
• Product Code: DRB
• UDI-Device Identifier: 00813132022990
• UDI-Public: (01)00813132022990(17)270409(10)0303453482
• Combination Product (Y/N): N
• 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): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/03/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 518-018
• Device Catalogue Number: 518-018
• Device Lot Number: 0303453482
• 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: 06/26/2025
• Initial Report FDA Received Date: 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/09/2025
• 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: SPECTRANETICS 11F TIGHTRAIL DILATOR SHEATH.; SPECTRANETICS 13F TIGHTRAIL DILATOR SHEATH.; SPECTRANETICS LLD #1 LEAD LOCKING DEVICES.; ST. JUDE MEDICAL 1388TC RA PACING LEAD.; ST. JUDE MEDICAL 1388TC RV PACING LEAD.; ST. JUDE MEDICAL 1688TC RV ICD LEAD.
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Race: Black Or African American