MAUDE Adverse Event Report: SPECTRANETICS CORPORATION LLD #2 LEAD LOCKING DEVICE; STYLET, CATHETER

Model Number	518-019
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	10/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A lead extraction procedure commenced to remove a right atrial (ra) and a right ventricular (rv) lead due to cied system/pocket infection.Spectranetics lld #2 lead locking devices (lld #2s), along with suture and femoral snares, were used to provide traction.Beginning with a spectranetics 11f tightrail sub-c rotating dilator sheath, then switching to an 11f tightrail (long), the rv lead was removed without issues.Next, the 11f tightrail sub-c was used on the ra lead, encountering snowplowing of the lead (lead insulation bunching up on itself) occurred in the innominate region.A 13f tightrail (long) was used to advance over the snowplowed region, and the ra lead was removed; however, a pericardial effusion was detected via transesophageal echocardiography (tee).While the physician was examining the ra lead, which had significant tissue on the tines at the lead's tip, the patient's blood pressure dropped.Rescue efforts began immediately, including rescue balloon and sternotomy.A perforation of the right atrial appendage (raa) was discovered and repaired.An innominate perforation was also discovered during the repair; however the physician felt this was related to the saw used during the rescue, and unrelated to any spectranetics device.The patient survived the procedure.This report captures the lld #2 providing traction within the ra lead which may have caused or contributed to the perforation (since snaring was also providing traction), requiring intervention.There was no alleged malfunction of any spectranetics devices in use during the procedure.
Additional Manufacturer Narrative
D4): device lot number, expiration date unk.Partial udi populated.H3): the device was discarded, thus no investigation could be completed.H4): device manufacture date unk because lot number unk 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.
Additional Manufacturer Narrative
**udi related data quality updates only** d4): correction: removing primary di number from udi# field.The lot number was not provided, thus an entire udi# is unavailable.G3): on 11jul2024, the manufacturer received fda email correspondence identifying a discrepancy in the udi information (section d of 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 #2 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: 18145033
• Report Number: 3007284006-2023-00069
• Device Sequence Number: 12509618
• Product Code: DRB
• UDI-Device Identifier: 00813132023010
• UDI-Public: 00813132023010
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2024

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 Model Number: 518-019
• Device Catalogue Number: 518-019
• 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: 07/11/2024
• Initial Report FDA Received Date: 11/15/2023
• Supplement Report FDA Received Date: 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: ABBOTT 1342T RA PACING LEAD.; ABBOTT 1342T RV PACING LEAD.; SNARE MANUFACTURER/TYPE UNK.; SPECTRANETICS 11F TIGHTRAIL DILATOR SHEATH.; SPECTRANETICS 11F TIGHTRAIL SUB-C DILATOR SHEATH.; SPECTRANETICS 13F TIGHTRAIL DILATOR SHEATH.; SPECTRANETICS LLD #2 IN RV LEAD.; SUTURE MANUFACTURER/TYPE UNK.
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White