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

Model Number	518-067
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Iatrogenic Source (2498); Cardiac Perforation (2513)
Date of Event	09/17/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
Patient's date of birth unavailable.
Event or Problem Description
A lead extraction procedure commenced to remove three leads: a right atrial (ra), right ventricular (rv) and left ventricular (lv) due to cied system/pocket infection.A spectranetics lead locking devices (lld) were used within each lead to act as a traction platform to aid in extraction.After successful extraction of the ra lead and a partial lv extraction (details of the partial lv lead extraction unknown, but reportedly did not result in an adverse event), the surgeon began attempts to extract the rv icd lead using a spectranetics tightrail rotating dilator sheath in addition to the lld.It was reported that no externalization of the blue high voltage wire was seen on ct scan prior to the extraction.During attempted extraction of the rv lead, the patient''s blood pressure dropped when the coil of the rv lead reportedly came off the ventricular wall and the lead retracted into the tightrail sheath.At the time, the tightrail device was 3 centimeters up the coil of the rv lead when the lead became free.The philips representative, present at the procedure, observed the two electrodes (pacing and sensing) still present in the apex wall.Rescue efforts began immediately, including sternotomy, blood products and bypass.Despite attempts to rescue the patient, the patient died.There was no alleged malfunction of any spectranetics devices during the patient procedure.

• 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: 10678394
• Report Number: 1721279-2020-00207
• Device Sequence Number: 3025910
• Product Code: DRB
• UDI-Device Identifier: 00813132023065
• UDI-Public: (01)00813132023065(17)210605(10)FLK19F04A
• Combination Product (Y/N): Y
• Initial Reporter Country: FR
• 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
• Report Date (Section B): 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/05/2021
• Device Model Number: 518-067
• Device Catalogue Number: 518-067
• Device Lot Number: FLK19F04A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/14/2020
• 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: SPECTRANETICS LEAD LOCKING DEVICES; SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH; ST. JUDE MEDICAL LV LEAD MODEL UNKNOWN; ST. JUDE MEDICAL RA LEAD MODEL UNKNOWN; ST. JUDE MEDICAL RV ICD LEAD MODEL UNKNOWN
• Outcome Attributed to Adverse Event: Death
• Patient Age: 70 YR
• Patient Weight: 90