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

Model Number 518-062

Device Problem Mechanical Problem (1384)

Patient Problems Iatrogenic Source (2498); Device Embedded In Tissue or Plaque (3165)

Event Date 04/18/2019

Event Type  Injury  

Manufacturer Narrative

Patient weight was unavailable from the facility.Device lot number and expiration date are not available from the facility.Device manufacture date is dependent on the device lot number, thus is unavailable.Device remains within patient.Therefore, no device evaluation will be performed.Physician did not attempt to unlock lld due to the emergent complications of the case.Physician has been made aware that the device is not intended for permanent implant.

Event Description

A right sided access lead extraction procedure commenced to remove 4 leads: three right ventricular (rv) leads and one right atrial (ra) lead due to need for mri, non functional leads, redundant leads and noise on the lead.The case was high risk and a sternotomy was performed since the patient was to have concomitant coronary artery bypass surgery in the same procedure.Lead locking devices (lld's) were placed within each of the leads as a traction platform.The physician successfully removed 2 leads (rv and ra) using an 11fr tightrail mini to gain venous access, then proceeded to use an 11fr tightrail (long).The device required a lot of manual handling to extract, but both leads came out with no complications.With the remaining rv leads, one which was a fineline product, difficulties were encountered.Due to the difficulties encountered, (please see mdrs 1721279-2019-00095 and 1721279-2019-00096 for further details regarding the complications encountered), the fineline rv lead extraction was abandoned and the physician cut the lld and capped it within the lead which was left in the patient.

• 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: 8713445
• MDR Text Key: 148461089
• Report Number: 1721279-2019-00102
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023072
• UDI-Public: 00813132023072
• Combination Product (y/n): Y
• Reporter Country Code: AS
• 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: 01/01/2005,05/23/2019

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
• Device Lot Number: UNAVAILABLE
• 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: 05/23/2019
• Initial Date FDA Received: 06/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BSC FINELINE RV PACING LEAD; SPECTRANETICS 11F TIGHTRAIL DILATOR SHEATH; SPECTRANETICS 11F TIGHTRAIL MINI DEVICE; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; ST. JUDE 1346T RV PACING LEAD; ST. JUDE 1488 RA PACING LEAD; ST. JUDE 2088T RV PACING LEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR