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

Model Number 545-513

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation of Vessels (2135)

Event Date 10/11/2023

Event Type  Death  

Manufacturer Narrative

H3): the device was discarded, thus no investigation could be completed.H6): perforation of vessels and death 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.

Event Description

A lead extraction procedure commenced to remove a right atrial (ra) and two right ventricular (rv) leads due to non function.Spectranetics lead locking devices (llds) were inserted into the leads to provide traction.Beginning with a 13f tightrail rotating dilator sheath on the ra lead, the blades stopped actuating after one hour of use; however, the ra lead was extracted successfully, and the tightrail was discarded.Next, using a new 13f tightrail, one of the rv leads was extracted without any issues.Then, using the same 13f tightrail, the second rv lead was extracted.At that time, the patient's blood pressure dropped, and rescue efforts began, including rescue balloon and sternotomy.An approximately 5 cm long perforation was discovered in the innominate vein.Repair was attempted, but the patient had lost too much blood and did not survive.This report captures the second 13f tightrail in use when the perforation occurred, requiring intervention but resulting in death.There was no alleged malfunction of the second 13f tightrail in use during the procedure.

• Brand Name: TIGHTRAIL ROTATING DILATOR SHEATH
• Type of Device: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 18144378
• MDR Text Key: 328205166
• Report Number: 3007284006-2023-00063
• Device Sequence Number: 1
• Product Code: DRE
• UDI-Device Identifier: 00813132021658
• UDI-Public: (01)00813132021658(17)250523(10)FRJ23E23A
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K150360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/15/2023

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
• Device Operator: Health Professional
• Device Model Number: 545-513
• Device Catalogue Number: 545-513
• Device Lot Number: FRJ23E23A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ABBOTT DURATA RV ICD LEAD.; ABBOTT RA PACING LEAD MODEL UNK.; RV LEAD MANUFACTURER/TYPE UNK.; SPECTRANETICS 13F TIGHTRAIL DILATOR SHEATH.; SPECTRANETICS LEAD LOCKING DEVICES.
• Patient Outcome(s): Life Threatening; Required Intervention; Death
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White