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 Code	Cardiac Perforation (2513)
Date of Event	01/31/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Cardiac perforation is a known risk of complication with use of the tightrail device.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.
Event or Problem Description
A lead extraction procedure commenced to remove a right atrial (ra) and a right ventricular (rv) lead due to non function.Spectranetics lead locking devices were inserted into the leads to provide traction.Multiple spectranetics devices (glidelight laser sheath, 13f tightrail rotating dilator sheath) were used in the procedure.The ra was successfully removed.During removal of the rv lead using the 13f tightrail and its outer sheath, the outer sheath encountered dense tissue.Once it passed through the tissue, unintended forward momentum caused it to perforate the rv.The patient''s blood pressure dropped and imaging detected the injury.The rv lead was removed.Rescue efforts began, including bypass and sternotomy.The rv perforation was repaired and the patient survived the procedure.This event captures the 13f tightrail''s outer sheath which caused the perforation, requiring intervention.There was no alleged malfunction of any spectranetics devices 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): SPECTRANETICS; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-2465
• MDR Report Key: 16432763
• Report Number: 1721279-2023-00025
• Device Sequence Number: 2645574
• Product Code: DRE
• UDI-Device Identifier: 00813132020880
• UDI-Public: 00813132020880
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 02/23/2023

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/23/2023
• 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: OSCOR PY52BV RA PACING LEAD; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS GLIDELIGHT LASER SHEATH; SPECTRANETICS LEAD LOCKING DEVICES; ST. JUDE MEDICAL 1038T RV PACING LEAD
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Age: 88 YR
• Patient Sex: Male