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

Model Number	545-513
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Perforation of Vessels (2135); Great Vessel Perforation (2152)
Date of Event	03/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient weight unavailable.Device lot number, expiration date unavailable.Device manufacture date unavailable because lot number unavailable.
Event or Problem Description
It was reported to a philips representative on 22 mar 2021 that on (b)(6) 2021, a lead extraction procedure commenced to remove a right ventricular (rv) and a right atrial (ra) lead due to redundant leads (class 2 indication).It was reported that the patient had a dual chamber system.Prior to the procedure, both leads were cut and prepped in normal fashion for extraction.The rv lead lumen had an obstruction and a spectranetics lead locking device (lld) was inserted into the rv lead, but was not able to pass further than the subclavian vessel.It was noted by a cardiac management representative present in the case that the surgeon applied a lot of force trying to advance a clearing stylet through the obstruction present in the rv lead.It was decided at that time to only pursue extraction of the ra lead.A spectranetics glidelight laser sheath was used first to attempt extraction of the ra lead, but progress stalled.Next, a spectranetics 13f tightrail rotating dilator sheath was used, and the ra lead was successfully extracted.The rv lead was capped and abandoned (the lld had been removed from the rv lead prior, so only the rv lead itself was capped).Sheaths were pulled, and the pocket was closed.15-20 minutes post-extraction, the patient's blood pressure dropped and an effusion was detected.Rescue efforts began, and a sternotomy was performed.A tear in the patient's innominate/superior vena cava (svc) region was discovered.The repair was successful and the patient survived the procedure.There was no alleged malfunction of the tightrail device in use during the procedure.This report is being submitted to capture the tightrail device being used in the area of injury (it was reported that the glidelight device did not reach the area of injury before progress stalled).
Additional Manufacturer Narrative
H3): the device was discarded, thus no investigation could be completed.H6): added codes: 4755, 4619, 4621.

• 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: 11689680
• Report Number: 1721279-2021-00063
• Device Sequence Number: 14198313
• Product Code: DRE
• UDI-Device Identifier: 00813132020897
• UDI-Public: 00813132020897
• Combination Product (Y/N): Y
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K150360
• Number of Events Summarized: 123
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2021

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: 545-513
• Device Catalogue Number: 545-513
• Device Lot Number: UNAVAILABLE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/22/2021
• Supplement Date Received by Manufacturer: 06/06/2021
• Initial Report FDA Received Date: 04/19/2021
• Supplement Report FDA Received Date: 06/16/2021
• 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: BOSTON SCIENTIFIC 0180 RV ICD LEAD; MEDTRONIC 5076 RA PACING LEAD; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS GLIDELIGHT LASER SHEATH; SPECTRANETICS LEAD LOCKING DEVICE
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 60 YR