MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model Number	545-511
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Perforation of Vessels (2135); Iatrogenic Source (2498)
Date of Event	05/29/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
Patient weight unavailable.Device lot number, expiration date unavailable.Device manufacture date unavailable because lot number 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) lead due to cied system/pocket infection.The rep present at the procedure stated the leads had to come out due to the infection.Spectranetics lead locking devices (lld's) were inserted in each lead to act as traction platforms to aid in lead extraction.A spectranetics 11f tightrail rotating dilator sheath was used to successfully remove the rv and ra leads; the lv lead was left to extract last because the team anticipated that the type of lv lead (starfix) was likely to be extremely difficult to remove.Using the tightrail device, the physician freed up the lv lead all the way to the coronary sinus (cs) opening (os) but could not get the lobes of the lv lead to retract back.It was reported that using the tightrail and traction, it appeared that the coronary sinus was inverting on itself, and was difficult to tell at times where the tightrail device was located within the vasculature.While the tightrail was in use near the area of the cs os, the patient's blood pressure dropped.The surgeon performed a subxyphoid window and drained the pericardium, and the patient's blood pressure stabilized, but the lv lead and the lld within the lead remained.The physician then removed the tightrail device, and began to work from a femoral access to remove the lv lead with a snare.During snaring, the patient's blood pressure dropped even further.Rescue efforts commenced, including sternotomy and bypass.The physician felt that an initial injury was created near the cs os, involving the tightrail device, and while snaring, there was either an extension of the same injury near the cs os, or in another location within the cs (please refer to mdr #1721279-2020-00124 which captures the second injury that occurred while snaring, and the spectranetics lld device was still within the lv lead in the cs).This report captures the initial injury near the cs os while the tightrail device was in use, necessitating a subxyphoid window to drain the pericardium.The physician successfully repaired the injury but unfortunately, the patient coded and died two days later on (b)(6) 2020.

• Brand Name: SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 10157659
• Report Number: 1721279-2020-00125
• Device Sequence Number: 3184813
• Product Code: DRE
• UDI-Device Identifier: 00813132020880
• UDI-Public: 00813132020880
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K150360
• 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): 05/29/2020
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 545-511
• Device Catalogue Number: 545-511
• 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: 05/29/2020
• Initial Report FDA Received Date: 06/16/2020
• 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: MEDTRONIC 4076 RA PACING LEAD; MEDTRONIC 4196 LV PACING LEAD; MEDTRONIC 6947 RV PACING LEAD; SNARE MANUFACTURER UNKNOWN; SPECTRANETICS LEAD LOCKING DEVICES
• Outcome Attributed to Adverse Event: Death
• Patient Age: 74 YR
• Date Report Sent to FDA: 01/01/2005