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	Low Blood Pressure/ Hypotension (1914); Iatrogenic Source (2498)
Date of Event	12/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient's weight unavailable.
Event or Problem Description
A philips representative was informed that a lead extraction procedure commenced to extract a right ventricular (rv) and a right atrial (ra) lead due to non function.Spectranetics lead locking devices (lld's) and a spectranetics 12f glidelight laser sheath were in use to aid in lead extractions.According to the report, imaging prior to the procedure showed no concerns.The extractions went smoothly and the physicians began working on replacing the system and implanting new leads.While suturing the pocket closed after the procedure, the patient reportedly coughed really hard and the blood pressure then dropped.Rescue efforts began immediately, including sternotomy.When the surgeon opened the chest, they noticed that the patient's superior vena cava (svc) was shredded.Attempt to repair the svc was made but was not successful and the patient expired.The physicians believe that the svc tear may have occurred while cutting open the patient's chest, as there were no hemodynamic changes noted during the procedure.It could not be confirmed what caused the initial blood pressure drop after the patient coughed really hard; it was thought that it may have been due to a small puncture that quickly healed itself during the lead extraction procedure and then reopened when the patient coughed hard, or there may have been a small effusion that worsened during implantation.Although the patient died post-sternotomy, the patient was hemodynamically stable during the entire lead extraction procedure, so no spectranetics device was determined to have caused or contributed to the patient's death.However, because the cause of the initial blood pressure drop cannot be confirmed and the glidelight device was reportedly in use during the lead extraction procedure, this report is being conservatively submitted.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: 11132005
• Report Number: 1721279-2021-00004
• Device Sequence Number: 896537
• Product Code: MFA
• UDI-Device Identifier: 00813132020323
• UDI-Public: (01)00813132020323(17)220729(10)FGA20G23A
• Combination Product (Y/N): Y
• Initial Reporter State: NM
• 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): 12/09/2020

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: 07/29/2022
• Device Model Number: 500-301
• Device Catalogue Number: 500-301
• Device Lot Number: FGA20G23A
• 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: 01/07/2021
• 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: Life Threatening; Required Intervention
• Patient Age: 78 YR