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); Vascular Dissection (3160)
Date of Event	11/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient's weight unk.Other relevant history unk.Device lot number, expiration date unk.The device was discarded, thus no investigation could be completed.Device manufacture date unk because lot number unk.
Event or Problem Description
A lead extraction procedure commenced to remove a right atrial (ra) and a right ventricular (rv) lead due to nonfunction.Both of these leads had been cut (at the level of the ra) by a surgeon in a prior open heart procedure (the leads were cut and listed inactive on (b)(6) 2020).For the lead extraction procedure, both of the leads were prepped with a cook medical liberator tip locking device, to provide traction.A spectranetics 13f tightrail rotating dilator sheath was used, and the physician advanced over the leads, followed by a spectranetics 16f glidelight laser sheath, and back to the 13f tightrail device.During its use in the procedure, the 16f glidelight device broke where the catheter connects to the laser sheath ''hub'' and exposed fibers were observed, outside of the patient.The cause of the break was reported to be from torquing the catheter (mdr 1721279-2021-00027).While removing the final lead (unable to determine lead location since both leads had been previously cut) and while the 13f tightrail device was in use, the patient's blood pressure dropped then stabilized.The physician noted there was higher pressure blood loss from the pocket, and the patient's mediastinum looked slightly enlarged.An arteriogram was performed, and a arterio-venous (av) fistula was discovered.Interventional cardiology, vascular surgery and cardiothoracic surgery joined the physician to strategize the best repair option for the patient.It is unknown what access was used to intervene, but dissections of both the left carotid and innominate arteries, along with perforation of the innominate vein, were successfully repaired.The patient survived the procedure.This report captures the 13f tightrail device in use when the av fistula occurred.There was no alleged malfunction of the tightrail device in use during the procedure.

• 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
• Manufacturer (Section G): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921
• MDR Report Key: 12829467
• Report Number: 1721279-2021-00226
• Device Sequence Number: 1492209
• Product Code: DRE
• UDI-Device Identifier: 00813132020897
• UDI-Public: 00813132020897
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K150360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/03/2021

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2021
• Initial Report FDA Received Date: 11/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: COOK MEDICAL LIBERATOR TIP LOCKING DEVICES; MEDTRONIC 5076-52 RA PACING LEAD; MEDTRONIC 5076-58 RV PACING LEAD; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White