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

Model Number	518-067
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Perforation of Vessels (2135); Iatrogenic Source (2498)
Date of Event	11/20/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: LLD
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 8174237
• Report Number: 1721279-2018-00174
• Device Sequence Number: 2142423
• Product Code: DRB
• UDI-Device Identifier: 00813132023065
• UDI-Public: 00813132023065
• Combination Product (Y/N): Y
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K142116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/20/2018
• Report Date (Section F): 01/01/2005

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
• Operator of Device: Health Professional
• Device Model Number: 518-067
• Device Catalogue Number: 518-067
• Device Lot Number: UNAVAILABLE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2018
• Initial Report FDA Received Date: 12/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS GLIDELIGHT LASER SHEATH
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 67 YR
• Date Report Sent to FDA: 01/01/2005