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	Death (1802); Perforation of Vessels (2135); Great Vessel Perforation (2152); Iatrogenic Source (2498)
Date of Event	12/18/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
Patient's date of birth unavailable.Patient's weight unavailable.Device lot number and expiration date unavailable.Device manufacture date unavailable because device lot number unavailable.
Event or Problem Description
A lead extraction commenced to extract a right ventricular (rv) lead due to the patient being occluded.A right atrial (ra) lead was present in the patient as well, and was not initially scheduled for extraction.The patient also needed an upgrade to a cardiac resynchronization therapy (crt) device.The occlusion was discovered at another hospital where the patient was initially scheduled to have the crt upgrade.The initial procedure plan was to extract the rv lead and then use the conduit for access for the upgrade.The rv lead was removed easily.However, the team was not able to pass a wire after the rv lead was removed, so they decided to take out the ra lead as well.After removing the ra lead, they were able to pass a wire through the occluded area, and proceeded with re-implant of a new ra, rv & coronary sinus (cs) lead.The case was completed, and they began to prepare the patient as normally, post procedure, removing groin lines, etc.It was at this time anesthesia noted that the patient's heart rate had increased.At that point they used fluoroscopy to look at the cardiac silhouette, and noted no movement.Chest compressions were started, a transthoracic echocardiogram (tte) was done.An effusion was noted in the right pleural space.A pericardiocentesis was performed, and 360cc of blood was removed.The patient was not responsive to chest compressions.Discussion was reportedly held between ct surgery and the physician, and it was decided that further intervention would not be warranted as the patient had died during this time.An autopsy showed a perforation near the azygous vein.

• 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: 9644688
• Report Number: 1721279-2020-00020
• Device Sequence Number: 2139424
• Product Code: MFA
• UDI-Device Identifier: 00813132020323
• UDI-Public: 00813132020323
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• 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): 01/03/2020
• 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 Model Number: 500-301
• Device Catalogue Number: 500-301
• Device Lot Number: UNAVAILABLE FROM FACILITY
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2020
• Initial Report FDA Received Date: 01/29/2020
• 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: BOSTON SCIENTIFIC 7740 RA PACING LEAD; BOSTON SCIENTIFIC 7741 RV PACING LEAD; SPECTRANETICS CVX-300 EXCIMER LASER; SPECTRANETICS LEAD LOCKING DEVICE
• Outcome Attributed to Adverse Event: Death
• Date Report Sent to FDA: 01/01/2005