MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS LEAD LOCKING DEVICE; LLD

Model Number 518-062

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

Patient Problems Death (1802); Tricuspid Regurgitation (2112); Iatrogenic Source (2498)

Event Date 09/11/2019

Event Type  Death  

Manufacturer Narrative

Device lot number and expiration date are not available from the facility.The device was discarded by the user.Device manufacture date is dependent on the device lot number, thus is unavailable.The device was discarded.There is no allegation of a malfunction.Therefore, no device evaluation will be performed.

Event Description

A cardiac lead management procedure commenced to remove 3 leads, due to non-functional and mri compatibility.Two right ventricular and 1 right atrial lead, two of which were 24 year old tined leads.A spectranetics lead locking device was utilized as the traction platform.The patient presented with moderate tricuspid regurgitation (tr) prior to the extraction.The patient had been notified that she would likely need to have her valve repaired, even with the extraction.After the extraction and subsequent re-implant (but while i was out of the room) it was noted that the patient had wide open tr which did not seem emergent.The extraction case was on wednesday (b)(6) 2019.Then the patient was taken in for surgery on saturday (b)(6) 2019 and had complications, one of which was blood loss which they could not treat due to patient's religious beliefs.Her family withdrew support on (b)(6) 2019.Based on the autopsy, the hospital reported that the death was multifactorial (including both the surgery, the extraction, and the refusal of blood product).

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: catherine eaton ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 9175202
• MDR Text Key: 161833894
• Report Number: 1721279-2019-00176
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023072
• UDI-Public: 00813132023072
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K142116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,09/23/2019

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
• Device Operator: Health Professional
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• 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: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 09/23/2019
• Initial Date FDA Received: 10/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MEDTRONIC 5076 PACING LEAD; MEDTRONIC 5524 PACING LEAD; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS GLIDELIGHT LASER SHEATH; SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH
• Patient Outcome(s): Death
• Patient Age: 59 YR