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

Model Number	545-511
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	01/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was discarded, thus no investigation could be completed.Although perforation of vessels is a known risk of complication with the tightrail or its outer sheath, this event has been determined to be use-related and a failure to follow instructions.It was reported that the physician advanced the outer sheath without proper traction (the ra lead was free).The ifu states: maintain appropriate traction on the lead being extracted during advancement of the tightrail sheath or outer sheath.As in all extraction procedures, use proper sheath technique.Maintain sturdy traction and a stable "rail" position with the lead while keeping coaxial alignment of the tightrail sheath to minimize the risk of vessel wall or cardiac structure damage.It was reported that the mobile c-arm device¿s image quality was poor.The ifu states: when the tightrail sheath is in the body, it should be manipulated only under fluoroscopic observation with radiographic equipment that provides high quality images.It was reported that the outer sheath was advanced without traction, not left in place.The ifu states: to retain venous access for re-implant, remove the lead through the tightrail sheath, keeping the tightrail sheath in place for guidewire insertion.Remove the tightrail device from the body after guidewire is inserted.If the optional outer sheath is being used, an alternative is to keep the outer sheath in place for guidewire insertion when removing lead and tightrail sheath.Remove the outer sheath from the body after guidewire is inserted.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 non-functional right atrial (ra) and right ventricular (rv) lead.A left ventricular (lv) lead and a second rv lead were present in the patient and were not targeted for extraction.A spectranetics lead locking device was inserted into each lead to provide traction.Multiple spectranetics devices (glidelight laser sheath, tightrail sub-c rotating dilator sheath, and an 11f tightrail rotating dilator sheath) were used in the procedure.The rv lead was successfully removed.While attempting ra lead removal, the 11f tightrail was the last device in use when the ra lead ultimately freed and retracted into the tightrail device.Due to the occluded vessel, the physician attempted to retain access with the tightrail's outer sheath to re-implant a new lead.However, due to the poor mobile c-arm image quality, it could not be determined how far the outer sheath was beyond the tip of the retracted ra lead.As the lead came back within the device at the innominate region, the physician advanced the outer sheath (without traction, because the ra lead was free), and inadvertently perforated the left innominate vein.The outer sheath was left in place to tamponade the perforation until the surgeon entered the room.Then the outer sheath was removed, and a rescue balloon was advanced to the area, which occluded the perforation.A sternotomy was performed and the innominate perforation was successfully repaired.The patient survived the procedure.This event captures the tightrail's outer sheath which perforated the innominate vein, 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: 16280840
• Report Number: 1721279-2023-00015
• Device Sequence Number: 17761038
• Product Code: DRE
• UDI-Device Identifier: 00813132021641
• UDI-Public: (01)00813132021641(17)231102(10)FRK21L02A
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 02/01/2023

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 Expiration Date: 11/02/2023
• Device Model Number: 545-511
• Device Catalogue Number: 545-511
• Device Lot Number: FRK21L02A
• 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: 02/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2021
• 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 4194 LV LEAD.; MEDTRONIC 6937 RV PACING LEAD.; MEDTRONIC 6940 RA PACING LEAD.; MEDTRONIC 6943 RV PACING LEAD.; MOBILE C-ARM MANUFACTURER/TYPE UNK.; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM.; SPECTRANETICS GLIDELIGHT LASER SHEATH.; SPECTRANETICS LEAD LOCKING DEVICES.; SPECTRANETICS TIGHTRAIL SUB-C DILATOR SHEATH.
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 129 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White