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

Model Number	518-067
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient date of birth unavailable.Patient weight unavailable.
Event or Problem Description
A lead extraction procedure commenced to remove a right ventricle lead due to infection.During the procedure, the physician was using a spectranetics tightrail rotating dilator sheath and a spectranetics lead locking device to extract the lead.While the physician was pulling the lead from the lld, it cracked between the distal loop and the proximal connector.The physician then used a cook medical needle's eye snare, by femoral access, to grab the lead from the distal end in order to free the lead and the tightrail.The tightrail was freed from the subclavian artery successfully and the lead was successfully extracted with the needle's eye snare through the femoral access.There was no injury to the patient.This report is being submitted due to the potential for serious injury with recurrence.
Additional Manufacturer Narrative
The initial mdr 1721279-2020-00041 created for this event is being corrected.In section b5 it was first reported that the spectranetics tightrail device was "freed from the subclavian artery".This was inaccurate information; the tightrail device was instead freed from the subclavian vein.This report is being submitted to correct the mdr and to accurately reflect the location within the patient anatomy.H3 other text : placeholder.
Event or Problem Description
A lead extraction procedure commenced to remove a right ventricle lead due to infection.During the procedure, the physician was using a spectranetics tightrail rotating dilator sheath and a spectranetics lead locking device to extract the lead.While the physician was pulling the lead from the lld, it cracked between the distal loop and the proximal connector.The physician then used a cook medical needle's eye snare, by femoral access, to grab the lead from the distal end in order to free the lead and the tightrail.The tightrail was freed from the subclavian vein successfully and the lead was successfully extracted with the needle's eye snare through the femoral access.There was no injury to the patient.This report is being submitted due to the potential for serious injury with recurrence.

• 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: 9742155
• Report Number: 1721279-2020-00041
• Device Sequence Number: 14081779
• Product Code: DRB
• UDI-Device Identifier: 00813132023065
• UDI-Public: (01)00813132023065(17)200921(10)FLK18J20A
• Combination Product (Y/N): Y
• Initial Reporter Country: IT
• PMA/510(K) Number: K142116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2020
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/21/2020
• Device Model Number: 518-067
• Device Catalogue Number: 518-067
• Device Lot Number: FLK18J20A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/04/2020
• Supplement Date Received by Manufacturer: 02/04/2020
• Initial Report FDA Received Date: 02/21/2020
• Supplement Report FDA Received Date: 03/03/2020
• 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: COOK MEDICAL NEEDLE'S EYE SNARE; SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEALTH
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 35 YR
• Date Report Sent to FDA: 01/01/2005