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

Model Number	518-067
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Iatrogenic Source (2498)
Date of Event	07/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient's weight was unavailable.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.Therefore, no device evaluation can be performed.
Event or Problem Description
A philips representative reported that a cardiac lead management procedure commenced to remove a non-functional/fractured right ventricular (ev) implantable cardioverter defibrillator (icd) lead.A spectranetics lead locking device (lld) was utilized as the traction platform for the extraction.The lld snapped at the rv lead fracture area, which was at the proximal end of the coil.The patient's blood pressure dropped at that time.Rescue efforts, including cpr and sternotomy, revealed that the superior vena cava (svc) was torn during the extraction (please see mdr 1721279-2019-00136, as the svc tear is not attributed to the lld device).Rescue efforts commenced including sternotomy, and the lead was removed during open heart.Note: 4076 right atrial (ra) lead, rep believes, was taken out during the open heart along with the 0292 right ventricular (rv) lead, due to being potentially dislodged.Original intention was to just take out 0292 rv lead.The patient survived the procedure.

• 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: 8852076
• Report Number: 1721279-2019-00137
• Device Sequence Number: 1504839
• Product Code: DRB
• UDI-Device Identifier: 00813132023065
• UDI-Public: 00813132023065
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K140775
• 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): 07/16/2019
• 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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 518-067
• Device Catalogue Number: 518-067
• 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: 07/16/2019
• Initial Report FDA Received Date: 08/01/2019
• 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: BOSTON SCIENTIFIC 0292 ICD LEAD; MEDTRONIC 4076 PACING LEAD; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS GLIDELIGHT LASER SHEATH; SPECTRANETICS TIGHRAIL ROTATING DILATOR SHEATH; SPECTRANETICS VISISHEATH DILATOR SHEATH
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 23 YR
• Date Report Sent to FDA: 01/01/2005