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

Model Number	560-011
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Perforation of Vessels (2135); Iatrogenic Source (2498)
Date of Event	02/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient weight was unavailable from the facility.The device was discarded.There is no allegation of a malfunction.Therefore, no device evaluation will be performed.
Event or Problem Description
A philips representative reported that during a cardiac lead management to extract a non-functional/redundant lead, the spectranetics tight-rail rotating dilator sheath was utilized.During lead extraction a decrease in the patient's blood pressure was observed.There was an injury to the superior vena cava (svc)/innominate vein/ right interjugular (rij)/ arch of azygos junction area.Rescue protocols were implemented.Rescue intervention was successful and at last report the patient was in stable condition.

• Brand Name: SPECTRANETICS TIGHTRAIL SUB-C ROTATING DILATOR SHEATH
• Common Device Name: TIGHTRAIL
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 8423153
• Report Number: 1721279-2019-00037
• Device Sequence Number: 14013673
• Product Code: DRE
• UDI-Device Identifier: 00813132022792
• UDI-Public: 00813132022792
• Combination Product (Y/N): Y
• Initial Reporter State: WA
• 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): 02/14/2019
• 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 Expiration Date: 11/27/2020
• Device Model Number: 560-011
• Device Catalogue Number: 560-011
• Device Lot Number: FRP18L27A
• 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: 02/14/2019
• Initial Report FDA Received Date: 03/14/2019
• 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: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 49 YR
• Date Report Sent to FDA: 01/01/2005