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

Model Number	560-013
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	08/24/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
Patient's date of birth unk.The device was discarded, thus no investigation could be completed.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 and replace the patient's pacemaker device, along with a right ventricular (rv), right atrium (ra), and left ventricular lead (lv) because of an infection that had been discovered a week prior to the procedure.The patient had the pacemaker device switched out five years ago due to age of the device.At that time, it was believed that she had a urinary tract infection (uti) and was given antibiotics.However, the patient continued to have elevated white blood cell count; therefore, the decision was made to start maintenance antibiotic therapy.Additionally, the patient was misdiagnosed with chronic obstructive pulmonary disease (copd) and had been on long term steroids.When starting the procedure, the physician discovered the infection was worse than expected and the pocket was eroded.The physician prepped all leads with spectranetics lead locking devices (llds) without any difficulty.The ra lead was successfully extracted first with minimal traction.The physician moved on to the rv lead where several adhesions were noted in the subclavian area, and proceeded with a spectranetics 13f tightrail sub-c.He advanced approximately three inches into the subclavian; however, before reaching the innominate, he was not able to remain coaxial and decided to switch to a longer tightrail device.Upon removing the tightrail device, the patient's blood pressure dropped and was discovered to be in pulseless electrical activity (pea).Rescue efforts began immediately, including rescue balloon and cardiopulmonary resuscitation (cpr).The cardiothoracic (ct) surgeon performed a sternotomy and discovered blood in the left thorax and a significant perforation in the left subclavian.There was also a small tear noted in the inferior vena cava (ivc), with cause unknown, and repaired successfully.Then, an attempt was made to repair the subclavian, but the severe infection, prolonged antibiotic and steroid use caused the patients tissue to become fragile and the sutures would not hold.The lv and rv leads, along with the llds, were never removed from the patient.Due to blood loss and heart failure, this caused the patient to go into cardiac arrest and did not survive the procedure.This report captures the tightrail that was in use when the subclavian and ivc perforation occurred, requiring intervention but resulting in death.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: nicole worford ; 9965 federal drive; colorado springs, CO 80921
• MDR Report Key: 15433477
• Report Number: 1721279-2022-00170
• Device Sequence Number: 12223685
• Product Code: DRE
• UDI-Device Identifier: 00813132022808
• UDI-Public: (01)00813132022808(17)230713(10)FRQ21G07A
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K161333
• 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): 09/15/2022

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: 07/13/2023
• Device Model Number: 560-013
• Device Catalogue Number: 560-013
• Device Lot Number: FRQ21G07A
• 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: 08/24/2022
• Initial Report FDA Received Date: 09/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2021
• 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: MEDTRONIC 4298 LV LEAD; MEDTRONIC 5076 RA PACING LEAD; MEDTRONIC 6947 RV ICD LEAD; SPECTRANETICS LEAD LOCKING DEVICES
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 125 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White