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	Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	12/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3): the device was discarded, thus no investigation could be completed.H6): cardiac perforation 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 capped single lumen right ventricular (rv) lead, and a triple lumen rv lead, due to non-function.To provide traction, a spectranetics lld e lead locking device (lld e) was inserted into the single lumen lead, and three spectranetics lld ez lead locking devices (lld ezs) were inserted into the triple lumen lead.Beginning with a spectranetics 13f tightrail sub-c rotating dilator sheath on the single lumen lead, advancement was made to the innominate/superior vena cava (svc) junction.Next, a spectranetics 16f glidelight laser sheath was used, progressing into the heart, then advancing without lasing to the lead''s tip.Light traction was applied by the lld e, and the lead tip came free.The glidelight was pulled back near the inferior vena cava (ivc) region, the lead was removed, and a guide wire was placed to prepare for re-implantation of a new lead.The patient''s blood pressure slowly dropped, but no injury was evident.The glidelight was removed, and at that time, a pericardial effusion was noted via transesophageal echocardiography (tee).Rescue efforts began, including rescue balloon and sternotomy.A small, anterior wall rv perforation was discovered and repaired, and a new lead was implanted.The decision was made to abandon the extraction attempt of the triple lumen lead.Attempts were made to unlock each lld from the lead, but were unsuccessful.The first lumen/lld (mdr #3007284006-2024-00010), the second lumen/lld (mdr #3007284006-2024-00011), and the third lumen/lld (mdr #3007284006-2024-00012) were cut and capped and remained in the patient.The patient survived the procedure.This report captures the lld e providing traction within the single lumen lead when the perforation occurred, requiring intervention.There was no alleged malfunction of the lld e in use during the procedure.
Additional Manufacturer Narrative
D4): upon record review 13sep2024, it was discovered that the device udi had been incorrectly populated in the initial mdr.Udi corrected to: (b)(4).All other fields remain accurate as listed in the initial mdr.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: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-2465
• MDR Report Key: 18518487
• Report Number: 3007284006-2024-00009
• Device Sequence Number: 12431404
• Product Code: DRB
• UDI-Device Identifier: 00813132023058
• UDI-Public: (01)00813132023058(17)240513(10)FLJ22E12A
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/13/2024
• Device Model Number: 518-039
• Device Catalogue Number: 518-039
• Device Lot Number: FLJ22E12A
• 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: 09/13/2024
• Initial Report FDA Received Date: 01/16/2024
• Supplement Report FDA Received Date: 09/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2022
• 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 4068 CAPPED RV PACING LEAD; MEDTRONIC SPO2 TRIPLE LUMEN RV ICD LEAD; SPECTRANETICS 13F TIGHTRAIL SUB-C DILATOR SHEATH; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LLD EZS IN TRIPLE LUMEN RV LEAD
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 93 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White