MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS 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	Great Vessel Perforation (2152); Pericardial Effusion (3271)
Date of Event	11/04/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A lead extraction procedure commenced to remove a right ventricular (rv) lead, leaving the right atrial (ra) and left ventricular (lv) leads in place within the patient.The physician began extraction attempt of the rv lead.A spectranetics lead locking device was inserted into the lead to provide traction.Using a spectranetics 16f glidelight laser sheath with its outer sheath, the physician encountered immediate lead to lead binding in the subclavian region.This binding caused the physician to reassess his plan and attempt to extract all leads and re-implant a new system.Physician then switched to the ra lead; inserting an lld for traction and using the same glidelight and outer sheath, the ra lead was extracted successfully.Physician then switched back to the rv lead, tip of the glidelight located in the innominate/superior vena cava (svc) junction, when the patient''s blood pressure dropped.Rescue efforts began immediately, including rescue balloon.A pericardial effusion was detected via transesophageal echocardiography (tee).Cpr performed and sternotomy followed.A pericardiocentesis was performed through the opening of the sternotomy.The patient''s heart was shocked, and the patient stabilized, along with stabilization of the effusion.To continue, the rv and lv leads were extracted post-sternotomy, and a new system was implanted.The theory was that traction pulled the lead off the svc lateral wall, bringing scar tissue and vessel tissue with it, creating a slight perforation in the svc.The rescue balloon likely tamponaded the area, allowing the vessel to clot off; no other repair was made to the svc.The patient survived the procedure.This report captures the lld providing traction to the rv lead when the perforation occurred, requiring intervention.There was no alleged malfunction of any spectranetics devices in use during the procedure.
Additional Manufacturer Narrative
The device was discarded, thus no investigation could be completed.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: SPECTRANETICS LEAD LOCKING DEVICE
• Common Device Name: STYLET, CATHETER
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921
• MDR Report Key: 15837541
• Report Number: 1721279-2022-00210
• Device Sequence Number: 6034589
• Product Code: DRB
• UDI-Device Identifier: 00813132023010
• UDI-Public: (01)00813132023010(17)240819(10)FLC22H17A
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 11/21/2022

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: 08/19/2024
• Device Model Number: 518-019
• Device Catalogue Number: 518-019
• Device Lot Number: FLC22H17A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2022
• Initial Report FDA Received Date: 11/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2022
• 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: ABBOTT 1388T RA PACING LEAD; BOSTON SCIENTIFIC 0125 RV ICD LEAD; BOSTON SCIENTIFIC 4513 LV LEAD; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LEAD LOCKING DEVICE IN RA LEAD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Life Threatening
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 96 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White