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	06/07/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
Patient weight is unavailable from the site.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 management procedure commenced to remove 2 pacing leads, one right atrial (ra) and one right ventricular (rv).A spectranetics glidelight laser sheath 500-301 was utilized to facilitate lead extraction.Heavy scarring stalled progress towards the entrance of the superior vena cava (svc).As the glidelight progressed past the svc, there was a decrease in the patient's blood pressure and rescue interventions began.Surgeon noticed a ¿5cm tear¿ of the svc.The tear was repaired over the course of 2 hours.Patient was stabilized.Brain damage was observed post case.Patient expired 3 days later.

• 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: 8732768
• Report Number: 1721279-2019-00112
• Device Sequence Number: 2572378
• Product Code: MFA
• UDI-Device Identifier: 00813132020323
• UDI-Public: 00813132020323
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• 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): 06/11/2019
• 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: 06/11/2019
• Initial Report FDA Received Date: 06/25/2019
• 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: Death; Life Threatening; Required Intervention
• Patient Age: 58 YR
• Date Report Sent to FDA: 01/01/2005