MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS LEAD LOCKING DEVICE; STYLET, CATHETER

Model Number	518-018
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Tricuspid Valve Insufficiency/ Regurgitation (4453)
Date of Event	09/08/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
A lead extraction procedure commenced to remove a right atrial (ra) and a right ventricular (rv) lead due to non function.A spectranetics lead locking device (lld) was inserted into the rv lead to provide traction.The physician used a spectranetics 13f tightrail rotating dilator sheath along with the lld and the rv lead was removed successfully.However, when the lead came out of the body it was noted that there was part of the tricuspid leaf that came out along with the lead.No hemodynamic changes were noted in the patient.The ra lead was then successfully removed.The procedure was completed and the patient survived.The surgeon is going to do a tricuspid valve transcatheter aortic valve replacement (tavr) on this patient at a later time, so tricuspid regurgitation is suspected.This report captures the lld providing traction to the rv lead when part of the tricuspid leaf came out along with the lead.There was no alleged malfunction of any spectranetics devices in use during the procedure.
Additional Manufacturer Narrative
Patient date of birth unk.Patient's weight unk.Patient's ethnicity/race unk.Relevant tests/laboratory data unk.Other relevant history unk.Device lot number, expiration date unk.The device was discarded, therefore no investigation could be completed.Device manufacture date unk because lot number unk.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Common Device Name: STYLET, CATHETER
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 12587111
• Report Number: 1721279-2021-00186
• Device Sequence Number: 3632346
• Product Code: DRB
• UDI-Device Identifier: 00813132022990
• UDI-Public: 00813132022990
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K990713
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/09/2021

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: 518-018
• Device Catalogue Number: 518-018
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 10/06/2021
• 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 0295 RV ICD LEAD; RA PACING LEAD MANUFACTURER AND MODEL UNK; SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH
• Outcome Attributed to Adverse Event: Other
• Patient Age: 73 YR