MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS 12F GLIDELIGHT LASER SHEATH

Model Number	500-301
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Perforation of Vessels (2135); Iatrogenic Source (2498)
Date of Event	06/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Operator of device code unavailable at this time.
Event or Problem Description
A procedure commenced to extract three leads: right atrial (ra), right ventricular (rv), and left ventricular (lv) due to infection.This was a very high risk extraction case.The ra lead was successfully removed first, with use of a glidelight 500-301 device and a lead locking device (lld).Once the ra lead was removed, dr then attempted removal of the lv lead.While lasing down the lv lead, there were significant adhesions noted in the innominate area.The glidelight was slowly advanced into the superior vena cava (svc).There appeared to be adhesions between the rv and lv leads in the svc ultimately, the lv lead was extracted.Then, as the rv lead was being prepared for extraction, the patient's blood pressure dropped sharply.Rescue efforts commenced immediately, including chest compressions, sternotomy and bypass.A tear was confirmed in the innominate and svc regions.A difficult repair was successful; the rv lead was removed at this time and the patient survived the procedure.
Additional Manufacturer Narrative
Code accepted by fda now populated within this field.

• Brand Name: SPECTRANETICS 12F GLIDELIGHT LASER SHEATH
• Common Device Name: GLIDELIGHT
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 7708359
• Report Number: 1721279-2018-00093
• Device Sequence Number: 1065366
• Product Code: MFA
• UDI-Device Identifier: 00813132020323
• UDI-Public: 00813132020323
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2018
• 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 Expiration Date: 01/02/2020
• Device Model Number: 500-301
• Device Catalogue Number: 500-301
• Device Lot Number: FGA17M21A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/28/2018
• Supplement Date Received by Manufacturer: 07/25/2018
• Initial Report FDA Received Date: 07/20/2018
• Supplement Report FDA Received Date: 07/31/2018
• 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 16F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER; SPECTRANETICS LEAD LOCKING DEVICE
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 85 YR
• Date Report Sent to FDA: 01/01/2005