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 Code	Great Vessel Perforation (2152)
Date of Event	06/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient's date of birth unavailable.Patient's weight unavailable.Patient's ethnicity unavailable.Patient's race unavailable.Relevant tests unavailable.Device lot number and expiration date unavailable.The device was discarded, thus no investigation could be completed.Device manufacture date unavailable because lot number unavailable.
Event or Problem Description
A philips employees became aware of an adverse event that occurred on 02 june 2021 where a superior vena cava (svc)/innominate tear occurred.Further information was obtained on 29 september 2021 from the physician¿s operation note.A lead extraction procedure commenced for removal and reimplantation of pacemaker device due to the device eroding through the skin of the patient.A right ventricular (rv), a right atrial (ra), and a left ventricular (lv) lead were to be removed to replace the device.The physician made an incision over the device on the left side of the chest.The device was showing through the skin and the leads were visible.The lv lead, with a dwell time of only two years, was targeted first and was successfully extracted.Spectranetics lead locking devices (lld) were then placed on the rv and ra lead to aid in extraction.Physician utilized 12f spectranetics glidelight laser sheath on the ra lead and began lasing from the subclavian vein through the innominate vein.There were multiple lead-on-lead binding sites, so the physician switched to the rv lead and advanced further down the svc.Once progress was made just past the svc and the ra, both leads appeared to be freed up and simultaneously retracted with simple tension.At this point, the patient¿s blood pressure dropped.There were no signs of effusion on transesophageal echocardiography (tee) and there was concern for an svc tear.The cardiothoracic surgeon immediately performed a sternotomy, and a 3 cm svc/innominate tear was discovered.Patient was given medication and patient¿s blood pressure rose.Repair and reimplantation was successful and patient survived the procedure.This report captures the glidelight device in use when the svc/innominate perforation occurred, requiring intervention.There was no alleged malfunction of any spectranetics devices in use during the procedure.

• 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: 12572633
• Report Number: 1721279-2021-00184
• Device Sequence Number: 19884055
• Product Code: MFA
• UDI-Device Identifier: 00813132020323
• UDI-Public: 00813132020323
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P960042 S070
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/07/2021

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2021
• Initial Report FDA Received Date: 10/04/2021
• 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: Required Intervention
• Patient Age: 83 YR