SPECTRANETICS LEAD LOCKING DEVICE 518-062

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2020-02-10 for SPECTRANETICS LEAD LOCKING DEVICE 518-062 manufactured by The Spectranetics Corporation.

Event Text Entries

[178573281] Patient's weight unavailable. Device lot number, expiration date unavailable. Device manufacture date unavailable.
Patient Sequence No: 1, Text Type: N, H10

[178573282] A lead extraction procedure commenced to remove three leads: a right atrial (ra) lead, a right ventricular (rv) lead and a left ventricular (lv) lead due to infection. Spectranetics lead locking devices (lld's) were present in each lead. The physician used a 14f glidelight laser sheath and progressed to the top half of the superior vena cava coil of the lead, when the coil started to stretch and unwind. The physician then chose to attempt extraction of the ra lead, which was successful with no complications. The physician then targeted the lv lead. The physician was able to advance to the mouth of the coronary sinus (cs). The tip of this lead appeared to still be attached, however, using very little force the tip suddenly came free and the lead was extracted successfully. The patient was stable and the physician continued. The physician proceeded to extract the rv lead again and due to the appearance of a "snowplow" affect on the lead, the physician chose to upsize to a 16f glidelight device to reduce force on the rv lead. As the physician was beginning to use the 16f glidelight device, anesthetist noted a rapid drop in the patient''s vital signs. At this point, the cardiac surgeon who was in the room confirmed with the physician to continue removal of the rv lead, which was successful. Rescue efforts began, including rescue device, cpr and sternotomy. A tear at the back of the heart (coronary sinus) was identified and the patient was prepared to be placed on bypass. The surgeon attempted to occlude the hole and administer hand compressions to the heart to circulate blood through the patient? S body. Once the patient was on bypass, repair to the injury began and was successful. Continued interventions were in place, including attempts to remove the patient from the bypass machine. The patient was placed on peripheral ecmo until the patient's heart was strong enough to function on its own. The patient survived the procedure. This report is being submitted to capture the lld which was present in the lv lead (within the cs, the area of injury) as the traction platform to aid in lead removal.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1721279-2020-00033
• MDR Report Key: 9687222
• Report Source: DISTRIBUTOR,FOREIGN,HEALTH PR
• Date Received: 2020-02-10
• Date of Report: 2020-01-17
• Date of Event: 2020-01-10
• Report Date: 2005-01-01
• Date Reported to FDA: 2005-01-01
• Date Reported to Mfgr: 2005-01-10
• Date Mfgr Received: 2020-01-17
• Date Added to Maude: 2020-02-10
• 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 LEAD LOCKING DEVICE
• Generic Name: LLD
• Product Code: DRB
• Date Received: 2020-02-10
• Model Number: 518-062
• Catalog Number: 518-062
• 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: 2020-02-10
• Device Sequence No: 101
• Device Event Key: 0

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention	2020-02-10