SPECTRANETICS 12F GLIDELIGHT LASER SHEATH 500-301

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-01-29 for SPECTRANETICS 12F GLIDELIGHT LASER SHEATH 500-301 manufactured by The Spectranetics Corporation.

Event Text Entries

[176884327] 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.
Patient Sequence No: 1, Text Type: N, H10

[176884328] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1721279-2020-00020
• MDR Report Key: 9644688
• Report Source: COMPANY REPRESENTATIVE,HEALTH
• Date Received: 2020-01-29
• Date of Report: 2020-01-03
• Date of Event: 2019-12-18
• Report Date: 2005-01-01
• Date Reported to FDA: 2005-01-01
• Date Reported to Mfgr: 2005-01-10
• Date Mfgr Received: 2020-01-03
• Date Added to Maude: 2020-01-29
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MRS. BARBARA CREEL
• Manufacturer Street: 9965 FEDERAL DRIVE
• Manufacturer City: COLORADO SPRINGS CO 80921
• Manufacturer Country: US
• Manufacturer Postal: 80921
• Manufacturer Phone: 719447-246
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: SPECTRANETICS 12F GLIDELIGHT LASER SHEATH
• Generic Name: GLIDELIGHT
• Product Code: MFA
• Date Received: 2020-01-29
• Model Number: 500-301
• Catalog Number: 500-301
• Lot Number: UNAVAILABLE FROM FACILITY
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: THE SPECTRANETICS CORPORATION
• Manufacturer Address: 9965 FEDERAL DRIVE COLORADO SPRINGS CO 80921 US 80921

Device Sequence Number: 101

• Product Code: ---
• Date Received: 2020-01-29
• Device Sequence No: 101
• Device Event Key: 0

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	2020-01-29