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 Codes	Great Vessel Perforation (2152); Pericardial Effusion (3271)
Date of Event	10/12/2022
Type of Reportable Event	Death
Event or Problem Description
A lead extraction procedure commenced to remove a right atrial (ra) and a right ventricular (rv) lead due to occlusion.The patient had a do not resuscitate order in place prior to the procedure.Spectranetics lead locking devices (llds) were inserted into each lead to provide traction.The physician began the extraction attempt of the ra lead with a spectranetics 11f tightrail sub-c rotating dilator sheath.Progress was made through the innominate vein, and then efforts switched to extract the rv lead, making progress to the superior vena cava (svc).It was noted that the patient's blood pressure was fluctuating and was treated.The physician switched to a spectranetics 11f tightrail (long) rotating dilator sheath, and while attempting extraction of the rv lead, significant back bleeding was noted from the pocket.Progress was made to the middle of the svc, but traction could not be maintained due to the dense makeup of the occlusion and jeopardized lead integrity.The physician switched efforts to the ra lead but still could not advance farther than the svc occlusion.A venogram was then performed on the right side to determine if the svc had opened for potential stent placement, but the patient's blood pressure dropped significantly and an svc perforation was discovered.Initially, no effusion was noted; however, chest compressions were initiated and a small pericardial effusion was detected.A pericardiocentesis was performed, but shortly afterward the patient expired.This report captures the 11f tightrail in use when the perforation occurred, requiring intervention but resulting in death.There was no alleged malfunction of any spectranetics devices in use during the procedure.
Additional Manufacturer Narrative
Patient's date of birth unk.Patient's weight unk.Other relevant history unk.The device was discarded, thus no investigation could be completed.Perforation of vessels are known risks 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.

• 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
• MDR Report Key: 15756741
• Report Number: 1721279-2022-00189
• Device Sequence Number: 4874187
• Product Code: DRE
• UDI-Device Identifier: 00813132021641
• UDI-Public: (01)00813132021641(17)230513(10)FRK21E12A
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 11/08/2022

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: 05/13/2023
• Device Model Number: 545-511
• Device Catalogue Number: 545-511
• Device Lot Number: FRK21E12A
• 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: 10/12/2022
• Initial Report FDA Received Date: 11/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2021
• 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 5076 RA PACING LEAD; MEDTRONIC 5076 RV PACING LEAD; SPECTRANETICS LEAD LOCKING DEVICES; SPECTRANETICS LEAD LOCKING DEVICES; SPECTRANETICS TIGHTRAIL SUB-C DILATOR SHEATH
• Outcome Attributed to Adverse Event: Life Threatening; Death; Required Intervention
• Patient Age: 39 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White