MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS 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	06/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient's weight unavailable.Patient''s ethnicity/race unavailable.Device lot number, catalog number and expiration date unavailable.The device was discarded, thus no investigation could be completed.Device manufacture date unavailable because device lot number unavailable.
Event or Problem Description
A lead extraction procedure commenced to remove three leads: a right ventricular (rv), a left ventricular (lv) and a right atrial (ra) lead due to non function.The leads had been implanted for 219 months.Spectranetics lead locking devices (llds) were inserted into each lead to provide traction to aid in the extractions.The physician used multiple devices to attempt lead extractions.Beginning with the rv lead, a spectranetics 16f glidelight laser sheath was used, followed by a spectranetics 13f tightrail sub-c rotating dilator sheath, following by the glidelight device again, with the addition of a spectranetics visisheath dilator sheath.Advancement to the superior vena cava (svc) was achieved, and the rv lead was disrupted but not removed.Attention was then turned to the lv lead.While attempting removal of the lv lead using the glidelight device and an lld to provide traction, the glidelight only advanced to the coronary sinus os and did not lase within the coronary sinus.The lv lead was successfully removed and it was reported that the ra lead was successfully removed as well.The physician then planned a femoral extraction of the rv lead.However, at that time the patient''s blood pressure dropped.Transesophageal echocardiography (tee) revealed an enlarging posterior effusion.Rescue efforts began.A pericardiocentesis was performed first, and the patient''s blood pressure normalized.Cardiothoracic surgery was called and a sternotomy was performed.A tear in the distal coronary sinus was discovered.The patient was placed on bypass and the tear was successfully repaired.Afterward, the rv lead remnant was removed via atriotomy, and the patient survived the procedure.This report is being submitted to capture the lld which provided traction to the lv lead and a life threatening coronary sinus tear occurred, requiring intervention.There was no alleged malfunction of the lld within the lv lead.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Common Device Name: STYLET, CATHETER
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 12207804
• Report Number: 1721279-2021-00135
• Device Sequence Number: 17324646
• Product Code: DRB
• UDI-Device Identifier: 00813132023058
• UDI-Public: 00813132023058
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/22/2021

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2021
• Initial Report FDA Received Date: 07/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 51 YR