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

Model Number 518-067

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

Patient Problems Perforation of Vessels (2135); Iatrogenic Source (2498)

Event Date 11/20/2018

Event Type  Injury  

Manufacturer Narrative

Patient weight could not be obtained from the site.Device was discarded and lot# was unobtainable from the site.Device manufactured date is dependent on the lot# and therefore cannot be determined.The device was discarded by the site.There is no allegation of a spectranetics product malfunction.Therefore, no device evaluation will be performed.

Event Description

A philips representative reported that during a cardiac lead management case, a perforation to the coronary sinus (cs) occurred.A spectranetics lead locking device (lld) 518-067 was utilized in the left ventricular (lv) lead.In this scenario, the type of lead usually used for right ventricular (rv) implantation was present in the lv.Rep stated that this lead is a little bigger than what is usually used for the lv.By applying traction/counter traction, the lead eventually came loose and was completely removed.Approximately 1 minute later, the anesthesiologist noticed some blood gathering via the trans-esophageal echo-cardiogram (tee).Rescue efforts were implemented.During thoracotomy the surgeon discovered a small perforation in the cs region and was able to stitch/repair the injury.The surgeon electrophysiologist closed the patient and the procedure was abandoned.Patient remained stable throughout.Although it was reported that there were 4 leads to be removed, only the lv was removed; the other leads remained in the patient.There were no lld's present in any of the leads 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: 8174237
• MDR Text Key: 130663916
• Report Number: 1721279-2018-00174
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023065
• UDI-Public: 00813132023065
• 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: 01/01/2005,11/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 518-067
• Device Catalogue Number: 518-067
• 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
• Date Manufacturer Received: 11/20/2018
• 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: SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS GLIDELIGHT LASER SHEATH
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 67 YR