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

Model Number	518-039
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Perforation of Vessels (2135); Pericardial Effusion (3271)
Date of Event	06/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A lead extraction procedure commenced to remove a left ventricular (lv) and right ventricular (rv) lead due to non-function.A spectranetics lld e lead locking device (lld e) was inserted into the lv lead, and a spectranetics lld ez lead locking device (lld ez) was inserted into the rv lead to provide traction.Beginning with a spectranetics 14f glidelight laser sheath on the lv lead, heavy binding sites were encountered.Next, targeting the rv lead with the 14f glidelight, progress stalled and switched to a spectranetics 11f tightrail sub-c rotating dilator sheath on the lv and rv lead.Then, utilizing the 14f glidelight on the lv lead, advancement was made down the coronary sinus (cs), past the superior vena cava (svc), when progress stalled again.Switching to the rv lead with a spectranetics 16f glidelight laser sheath, advancement stalled in the svc; therefore, a spectranetics 13f tightrail rotating dilator sheath was used, and made it past the svc when the rv lead broke.The intact lld ez, along with a portion of the rv lead were removed from the patient.Moving back the lv lead with the 14f glidelight, progress was made past the svc down to the cs, and while pulling traction with the lld e, the lead was removed; however, a pericardial effusion was detected and the patient¿s blood pressure dropped.Rescue efforts began, including pericardiocentesis and sternotomy.A cs perforation was discovered and repaired, and the distal tip of the rv lead remained in the patient.The patient survived the procedure.This report captures the lld e providing traction on the lv lead when the perforation occurred, requiring intervention.There was no alleged malfunction of any spectranetics devices in use during the procedure.
Additional Manufacturer Narrative
A3b) patient gender - not available from facility.H3) the lld e was discarded, thus no product investigation was performed.H6) per ifu, perforation is listed as a potential adverse event 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.

• Brand Name: LLD E 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: 25669794
• Report Number: 3007284006-2026-00386
• Device Sequence Number: 12171960
• Product Code: DRB
• UDI-Device Identifier: 00813132023058
• UDI-Public: (01)00813132023058(17)280202(10)0303694006
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K043401
• 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): 06/30/2026

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: 518-039
• Device Catalogue Number: 518-039
• Device Lot Number: 0303694006
• 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: 06/22/2026
• Initial Report FDA Received Date: 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/02/2026
• 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: BIOTRONIK 368346 LV LEAD.; BIOTRONIK 368346 RV PACING LEAD.; SPECTRANETICS 11F TIGHTRAIL SUB-C DILATOR SHEATH.; SPECTRANETICS 13F TIGHTRAIL DILATOR SHEATH.; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH.; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH.; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM.; SPECTRANETICS LLD EZ LEAD LOCKING DEVICE.
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 93 KG
• Patient Ethnicity: Hispanic
• Patient Race: White