MAUDE Adverse Event Report: SPECTRANETICS LEAD LOCKING DEVICE

Model Number SIZE E

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Exsanguination (1841); Perforation of Vessels (2135)

Event Date 04/10/2019

Event Type  Death  

Event Description

During laser defibrillator lead extraction, pt developed hypotension due to superior vena cava tear.Pt transferred to surgery.No obvious product malfunction.

• Brand Name: LEAD LOCKING DEVICE
• Type of Device: LEAD LOCKING DEVICE
• Manufacturer (Section D): SPECTRANETICS ; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 8670832
• MDR Text Key: 147082629
• Report Number: 8670832
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/30/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SIZE E
• Device Catalogue Number: 518-039
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/30/2019
• Distributor Facility Aware Date: 04/10/2019
• Event Location: Hospital
• Date Report to Manufacturer: 05/31/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/31/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 62 YR
• Patient Weight: 79