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	Great Vessel Perforation (2152); Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	12/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A lead extraction procedure commenced to remove a right ventricular (rv) and a right atrial (ra) lead due to needing upgraded to a crt-d device.The patient''s left subclavian vein was occluded and it was decided to extract the rv lead in order to gain access through the occlusion.Spectranetics lead locking devices (llds) were inserted into each lead to provide traction.Simple traction was applied to the rv lead, causing the lead to dislodge but not completely freed due to binding within the vasculature.A medtronic 15 mm amplatz gooseneck snare was inserted into the right groin to grasp the rv lead and apply traction, while a spectranetics 12f glidelight laser sheath was used from the pocket in order to free the lead.Advancement was made to the superior vena cava (svc)/ra junction with lasing occurring through the binding present in the area, when the patient''s blood pressure dropped.A pericardial effusion was detected via transesophageal echocardiography (tee).Rescue efforts began, including rescue balloon, pericardiocentesis, medications, and blood administration.Approximately 1,100 cc of blood was drained via pericardiocentesis.The patient was monitored and no additional growth in the effusion was noted.The physician was able to complete crt-d implantation from the patient''s right side, and the rv and ra leads were removed from the left side.At the end of the procedure, the effusion remained stable, and the patient survived the procedure.The physician believes he may have snared a small portion of tissue at the svc/ra junction, and the glidelight lased a small hole over the area which sealed itself off after pericardiocentesis.This event captures the 12f glidelight in use when the perforation occurred, requiring intervention.There was no alleged malfunction of any spectranetics devices in use during the procedure.
Additional Manufacturer Narrative
Patient''s date of birth unk.Device lot number, expiration date unk.The device was discarded, thus no investigation could be completed.Device manufacture date unk because lot number unk (b)(4).Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.

• 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
• Manufacturer (Section G): SPECTRANETICS; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921
• MDR Report Key: 16014400
• Report Number: 1721279-2022-00233
• Device Sequence Number: 6419062
• Product Code: MFA
• UDI-Device Identifier: 00813132020323
• UDI-Public: 00813132020323
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/20/2022

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2022
• Initial Report FDA Received Date: 12/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MEDTRONIC 15 MM AMPLATZ GOOSENECK SNARE; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LEAD LOCKING DEVICES; ST. JUDE MEDICAL 2088TC RA PACING LEAD; ST. JUDE MEDICAL 2088TC RV PACING LEAD
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Weight: 58 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White