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 company representative,foreig report with the FDA on 2020-01-10 for SPECTRANETICS LEAD LOCKING DEVICE 518-062 manufactured by The Spectranetics Corporation.

Event Text Entries

[177008626] Patient date of birth unavailable. Device lot number, expiration date unavailable. Device manufacture date unavailable.
Patient Sequence No: 1, Text Type: N, H10

[177008627] A lead extraction procedure commenced to remove two leads: a left ventricular (lv) lead and a right ventricular (rv) lead due to infection. First, a spectranetics lead locking device (lld) and tightrail devices were used to successfully extract the lv lead. The physician then used multiple spectranetics devices (glidelight, sightrail, lld and tightrail) to attempt extraction of the rv lead. While using a 13f tightrail device, the patient's blood pressure dropped while the tightrail device was in the distal part of the superior vena cava (svc) coil. Rescue efforts commenced immediately, including sternotomy, and an svc tear was discovered. The svc injury was repaired successfully and the patient survived the procedure at that time, and was urgently transferred to the or (please refer to mdr #1721279-2019-00218 which captures the svc injury). Additional information provided to the manufacturer on 18 dec 2019 reported that the rv lead was not removed from the patient's body due to the critical condition of the patient during the adverse event. A spectranetics lead locking device (lld) was present within the rv lead, and it was reported that the physician did not attempt to remove the lld from the rv lead. It is not known whether the rv lead/lld within the lead was removed once the patient was transferred to the or, or whether the rv lead/lld were cut and capped and left within the patient. It was also reported to the manufacturer on 18 dec 2019 that the patient died two days after the procedure on (b)(6) 2019. The cause of the patient's death is unknown, although information about cause of death was requested. There was no reported malfunction of any spectranetics devices in use during the procedure. This report is being submitted in the event that the lld had been cut and capped within the rv lead, and remained in the patient. In addition, although the patient died, there is no information provided that the death resulted from the injury, nor from the lld, if it was cut and capped and remained in the patient.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1721279-2020-00011
• MDR Report Key: 9575609
• Report Source: COMPANY REPRESENTATIVE,FOREIG
• Date Received: 2020-01-10
• Date of Report: 2019-12-18
• Date of Event: 2019-11-22
• Report Date: 2005-01-01
• Date Reported to FDA: 2005-01-01
• Date Reported to Mfgr: 2005-01-10
• Date Mfgr Received: 2019-12-18
• Date Added to Maude: 2020-01-10
• 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: 2020-01-10
• Model Number: 518-062
• Catalog Number: 518-062
• Lot Number: UNAVAILABLE
• 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: 2020-01-10
• Device Sequence No: 101
• Device Event Key: 0

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2020-01-10