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

Model Number	518-062
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	03/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A lead extraction procedure commenced to remove a right atrial (ra) lead due to non-function.A right ventricular (rv) and left ventricular (lv) lead were present within the patient, but not targeted for extraction.A spectranetics lld ez lead locking device (lld ez) was inserted into the ra lead to provide traction.Beginning with a spectranetics 14f glidelight laser sheath, progress stalled because the lead started to snowplow.Therefore, upsized to a spectranetics 16f glidelight laser sheath, along with a spectranetics large visisheath dilator sheath.Advancement was made to the innominate vein, and the lead freed from the heart.A new ra lead was implanted; however, the patient's blood pressure declined and a pericardial effusion was detected via transesophageal echocardiogram (tee).Rescue efforts began, including rescue balloon, pericardiocentesis, and sternotomy.An ra perforation was discovered and repaired, and the patient stabilized and survived the procedure.This report captures the lld ez 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.
Additional Manufacturer Narrative
A2) patient date of birth - not available from facility.A3b) patient gender - not available from facility.A4) patient weight - not available from facility.A5/a6) patient ethnicity and race - not available from facility.B6/b7) patient information regarding relevant tests/laboratory data or medical history - not available from facility.H3) the lld was discarded, thus no product investigation was performed.H6) per ifu, perforation is listed as a potential adverse event with use of lld devices.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
• 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: 24656377
• Report Number: 3007284006-2026-00090
• Device Sequence Number: 5118178
• Product Code: DRB
• UDI-Device Identifier: 00813132023072
• UDI-Public: (01)00813132023072(17)271001(10)0303594010
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K142116
• 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): 03/20/2026

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: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: 0303594010
• 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: 03/03/2026
• Initial Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2025
• 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: MEDTRONIC 4298 LV LEAD; MEDTRONIC 5076 RA PACING LEAD; MEDTRONIC 6947 RV PACING LEAD; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LARGE VISISHEATH DILATOR SHEATH
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 70 YR
• Patient Sex: Male