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); Cardiac Perforation (2513)
Date of Event	05/17/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
A procedure commenced to remove two leads: a right ventricular (rv) lead and a left ventricular (lv) lead, due to non-function.The spectranetics devices in use were a 12f and 14f glidelight, an 11f tightrail, and lead locking devices (lld's).The rv was successfully removed first, with a 14f laser and 11f tightrail.Then attempt was made to extract the lv lead using the 12f glidelight device, and the desire was to utilize an lld within the lv lead.However, the lld could not be advanced down the lead near the pocket, due to lead fracture.It was reported the physician was manipulating the glidelight within the coronary sinus (cs), and also lased with the glidelight while in the cs.The patient's blood pressure dropped after lv lead was extracted.Rescue efforts commenced immediately.An injury was discovered at the entry of the ostium of the cs and approximately 2 cm into the cs.Repair was successful and the patient survived the procedure.
Additional Manufacturer Narrative
B4) date correction.

• 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: 8670340
• Report Number: 1721279-2019-00094
• Device Sequence Number: 2131123
• Product Code: MFA
• UDI-Device Identifier: 00813132020323
• UDI-Public: (01)00813132020323(17)210207(10)FGA19A30A
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• 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,Followup
• Report Date (Section B): 05/17/2019
• 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 Expiration Date: 02/07/2021
• Device Model Number: 500-301
• Device Catalogue Number: 500-301
• Device Lot Number: FGA19A30A
• 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: 05/19/2019
• Supplement Date Received by Manufacturer: 08/18/2019
• Initial Report FDA Received Date: 06/05/2019
• Supplement Report FDA Received Date: 08/22/2019
• 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: MEDTRONIC 4194 LV PACING LEAD; MEDTRONIC 6947 RV PACING LEAD; SPECTRANETICS 11F TIGHTRAIL DILATOR SHEATH; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LEAD LOCKING DEVICE; MEDTRONIC 4194 LV PACING LEAD; MEDTRONIC 6947 RV PACING LEAD; SPECTRANETICS 11F TIGHTRAIL DILATOR SHEATH; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LEAD LOCKING DEVICE
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 53 YR
• Patient Weight: 109
• Date Report Sent to FDA: 01/01/2005