MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS 12F GLIDELIGHT LASER SHEATH; DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS

Model Number	500-301
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Iatrogenic Source (2498); Cardiac Perforation (2513)
Date of Event	11/27/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
This summary was compiled from procedure notes provided by the facility: a philips representative was present in a lead extraction procedure which commenced to remove a right ventricular (rv), right atrial (ra) and left ventricular (lv) due to bacteremia.Spectranetics lead locking devices (lld's) were inserted into each lead to provide traction to aid in extraction.In addition, multiple spectranetics tools were in use during the procedure.It was reported that the patient had a pre-existing pleural effusion noted at the start of the case, and a right sided chest tube was placed out of precaution.It was confirmed that no spectranetics devices were in use at the time the effusion was noticed.The physician began by using a 14f glidelight laser sheath, then switched to a tightrail 13f sub-c rotating dilator sheath.The physician then upsized to a 16f glidelight device.A byrd dilator sheath 11.5f was inserted into the subclavian vein over the ra lead.The physician then alternated tools between the tightrail sub-c device and the 16f glidelight device.While the 16f glidelight was in use, the ra lead was ultimately removed.The 16f glidelight device was reinserted then removed, and a 12f glidelight device was used to extract the lv lead.The lv lead was removed and the patient's blood pressure dropped.An injury to the coronary sinus was identified.A pericardial window was performed, with an incision made in the sub-xiphoid area and sternum.Tamponade subsided, and the effusion was relieved.The posterior aspect of the pericardium was packed with mesh soaked with thrombin and a pericardial drain was placed.Then the 16f glidelight was inserted, working to remove the rv lead.The rv lead was removed successfully.Re-implantation of a new system was completed at that time.The patient survived the procedure and transferred to ctcu.There was no alleged malfunction of any spectranetics device in use.This report is being submitted to capture the coronary sinus injury which was identified after the lv lead was removed and the 12f glidelight device was in use.

• Brand Name: SPECTRANETICS 12F GLIDELIGHT LASER SHEATH
• Common Device Name: DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 11041249
• Report Number: 1721279-2020-00257
• Device Sequence Number: 19088618
• Product Code: MFA
• UDI-Device Identifier: 00813132020323
• UDI-Public: (01)00813132020323(17)220807(10)FGA20H03A
• 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): 11/27/2020

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: 08/07/2022
• Device Model Number: 500-301
• Device Catalogue Number: 500-301
• Device Lot Number: FGA20H03A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/18/2020
• 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: 63 YR
• Patient Weight: 105