MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS GLIDELIGHT LASER SHEATH

Model Number	500-301
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Great Vessel Perforation (2152); Iatrogenic Source (2498)
Date of Event	06/13/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
Device lot number and expiration date are not available from the facility.The device was discarded by the user.Device manufacture date is dependent on the device lot number, thus is unavailable.The device was discarded.There is no allegation of a malfunction.Therefore, no device evaluation will be performed.
Event or Problem Description
A philips representative reported that a cardiac lead extraction procedure commenced to remove a malfunctioning right atrial (ra) lead.The ra lead was successfully removed with a spectranetics lead locking device and a spectranetics 12fr glidelight laser sheath.No hemodynamic changes were noted.After lead extraction 6f long sheath was inserted into the anatomy via the open pocket.An abbott ra lead was inserted to the level of the ra.The physician noted incorrect positioning, removed the lead, and conducted a venogram.Visible staining was noted in the superior vena cava (svc) area.Hemodynamic changes were noted.Rescue interventions commenced.The surgeon intervened with sternotomy.A 2 inch brachiocephalic to svc tear was repaired.Patient did not survive procedure.The glidelight functioned per design with no malfunction.The changes in hemodynamics and visible contrast staining in the epicardial space were noted after the attempted implant of the new ra lead.

• Brand Name: SPECTRANETICS GLIDELIGHT LASER SHEATH
• Common Device Name: GLIDELIGHT
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 8741266
• Report Number: 1721279-2019-00114
• Device Sequence Number: 16516403
• Product Code: MFA
• UDI-Device Identifier: 00813132020323
• UDI-Public: 00813132020323
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P960042
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/13/2019
• Report Date (Section F): 01/01/2005

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: 500-301
• Device Catalogue Number: 500-301
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2019
• Initial Report FDA Received Date: 06/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LEAD LOCKING DEVICE; ST. JUDE 2088TC LEAD
• Outcome Attributed to Adverse Event: Death; Hospitalization; Life Threatening; Required Intervention
• Patient Age: 76 YR
• Patient Weight: 66
• Date Report Sent to FDA: 01/01/2005