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

Model Number	560-011
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Great Vessel Perforation (2152); Iatrogenic Source (2498)
Date of Event	05/22/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
In the spectranetics tightrail sub-c rotating dilator sheath instructions for use (ifu), 4.Warnings, it states "the tightrail sub-c sheath should only be used to minimally enter the vessel.Do not attempt to enter the svc structure or attempt to navigate the tightrail sub-c sheath into bends beyond the convergence of the innominate and brachiocephalic veins as vessel wall or cardiac lead damage may occur".It was reported that the tightrail sub-c sheath came around the corner to the svc and an svc perforation was discovered.This was an approved procedure for an approved patient.
Event or Problem Description
A lead extraction procedure commenced to remove two leads: a right atrial (ra) and right ventricular (rv) lead due to infection.It was reported that significant infection was noted in the pocket and significant calcium noted on the leads.Spectranetics lead locking devices (lld's) were used in each lead to act as traction platoforms for the leads to aid in lead removal.The ra lead was targeted for removal first.A spectranetics tightrail sub-c rotating dilator sheath was used for the case.As the physician came around the corner to the superior vena cava (svc) with the device, the patient's blood pressure dropped.Rescue efforts commenced immediately, including use of rescue device.A sternotomy revealed an svc tear.The patient was placed on bypass pump and the physician attempted to repair the tear; however, there was reportedly not enough tissue and the tissues were too fragile to suture.Repair was attempted for several hours but the patient unfortunately died.

• 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: 10153574
• Report Number: 1721279-2020-00123
• Device Sequence Number: 2042741
• Product Code: DRE
• UDI-Device Identifier: 00813132022792
• UDI-Public: (01)00813132022792(17)210516(10)FRP19E16A
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K161333
• 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): 05/22/2020
• 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 Expiration Date: 05/16/2021
• Device Model Number: 560-011
• Device Catalogue Number: 560-011
• Device Lot Number: FRP19E16A
• 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: 05/22/2020
• Initial Report FDA Received Date: 06/15/2020
• 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; ST. JUDE MEDICAL 1388T RV PACING LEAD; ST. JUDE MEDICAL 1388TC RA PACING LEAD
• Outcome Attributed to Adverse Event: Death
• Patient Age: 88 YR
• Patient Weight: 65
• Date Report Sent to FDA: 01/01/2005