MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH

Model Number	560-011
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Codes	Iatrogenic Source (2498); Foreign Body In Patient (2687)
Date of Event	10/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device lot number, catalog number and expiration date unavailable from facility.Device manufacture date unavailable because device lot number is unavailable.
Event or Problem Description
A lead management procedure concluded when it was discovered that the device's outer teflon sheath was left in the patient's subclavian vein after the procedure.The outer sheath became dislodged from the tightrail sub-c device while inside the patient and was not caught upon removal of the device, and was not visualized since it is not radiopaque.The day after the procedure, a vascular surgery team surgically removed the outer sheath by re-opening the pocket and grabbing the outer sheath with forceps, safely pulling out the outer sheath.There was no reported patient harm during the event.

• Brand Name: SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH
• Common Device Name: TIGHTRAIL
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 9221128
• Report Number: 1721279-2019-00183
• Device Sequence Number: 11302223
• Product Code: DRE
• UDI-Device Identifier: 00813132022792
• UDI-Public: 00813132022792
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/01/2019
• 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: 560-011
• Device Catalogue Number: 560-011
• 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: 10/04/2019
• Initial Report FDA Received Date: 10/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Weight: 96
• Date Report Sent to FDA: 01/01/2005