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

Model Number	560-011
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Perforation of Vessels (2135)
Date of Event	06/07/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
Patient's weight unavailable.The device was discarded, thus no investigation could be completed.
Event or Problem Description
A lead extraction procedure commenced to remove a right atrial (ra) and a right ventricular (rv) lead due to redundant lead and needing to upgrade patient to an icd lead.This procedure was a right sided extraction.The physician began the procedure by using a spectranetics 11f tightrail rotating dilator sheath.He began by attempting extraction of the ra lead, but encountered stalled progression at the clavicle.He turned attention toward extraction of the rv lead, but stalled again.He then chose a spectranetics 11f tightrail sub-c device and stalled at the clavicle, switched leads again, stalled again, and at that time, both leads pulled back out together.The patient's blood pressure dropped at this time.The blood pressure drop was treated and the reimplantation of three new chest leads followed.However, the blood pressure dropped again.After this second blood pressure drop, the vascular surgeon was called but was not in the building.There were two ct surgeons that scrubbed in to assist with the intervention.It was reported that the patient's chest was filling with blood on the right side; a sternotomy was performed; patient was also placed on bypass.Two right subclavian tears were discovered.Unfortunately, the loss of blood due to the tears, even with surgical intervention, was not enough to save the patient's life and the patient died.There was no alleged malfunction of any spectranetics devices in use during the procedure.This report is being submitted to capture the tightrail sub-c device which was being used in the area of injury when the blood pressure dropped.

• 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: 12096068
• Report Number: 1721279-2021-00120
• Device Sequence Number: 11949928
• Product Code: DRE
• UDI-Device Identifier: 00813132022792
• UDI-Public: (01)00813132022792(17)220827(10)FRP20H27A
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/07/2021

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 Expiration Date: 08/27/2022
• Device Model Number: 560-011
• Device Catalogue Number: 560-011
• Device Lot Number: FRP20H27A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2021
• Initial Report FDA Received Date: 06/30/2021
• 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: OSCOR ELAFIX P2P744 RA PACING LEAD; OSCOR ELAFIX P2P752 RV PACING LEAD; SPECTRANETICS LEAD LOCKING DEVICES; SPECTRANETICS TIGHTRAIL 11F DILATOR SHEATH
• Outcome Attributed to Adverse Event: Death
• Patient Age: 80 YR