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	08/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A lead extraction procedure commenced to remove a right atrial (ra), a right ventricular (rv), and a left ventricular (lv) lead due to bacteremia.Prior to the procedure, a small effusion was noted, and existing lead vegetation was removed.Spectranetics lead locking devices (llds) were inserted into each lead to provide traction.The ra and rv leads were extracted successfully.Using a spectranetics 16f glidelight laser sheath to remove the lv lead, advancement was made to just under the clavicle.The lv lead pulled free and the existing effusion was noted to have grown; however, the patient remained stable.Due to the increased effusion that was detected after lv lead removal, a coronary sinus (cs) perforation was suspected with no intervention performed at that time.The procedure was completed and the patient survived.Later that evening a pericardiocentesis was performed to draw off blood that had accumulated in the pericardial sac, and the patient responded well to the intervention.However, it cannot be confirmed whether the lld within the lv lead caused or contributed to the suspected cs perforation.This report is being submitted conservatively for the lld present within the lv lead and a perforation was suspected, requiring intervention.There was no alleged malfunction of any spectranetics devices in use during the procedure.
Additional Manufacturer Narrative
A4): patient weight unk.D4): device serial number unk.H3): device was discarded, thus no investigation could be completed.H6): perforation of vessels 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.

• 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: jill jacoby ; 9965 federal drive; colorado springs, CO 80921 ; 719447-2465
• MDR Report Key: 17652335
• Report Number: 3007284006-2023-00018
• Device Sequence Number: 15296480
• Product Code: DRB
• UDI-Device Identifier: 20813132023052
• UDI-Public: (01)20813132023052(17)240513(10)FLJ22E12A
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/30/2023

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
• Initial Report FDA Received Date: 08/30/2023
• 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: LEAD VEGETATION REMOVAL DEVICE MFR UNK; MEDTRONIC 4198/88 LV LEAD; MEDTRONIC 5076/52 RA PACING LEAD; MEDTRONIC 6947/65 RV ICD LEAD; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LEAD LOCKING DEVICES
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White