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

Model Number	545-513
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Great Vessel Perforation (2152); Cardiac Perforation (2513)
Date of Event	10/28/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
H3): the tightrail was not returned, thus no returned product investigation was performed.H6): great vessel perforation, cardiac perforation, 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 or Problem Description
A lead extraction procedure commenced to remove a right ventricular (rv) lead due to non function (lead fracture).A right atrial (ra) lead was present in the patient as well, but was not targeted for extraction.A spectranetics lld ez lead locking device (lld ez) was inserted into the lead, with poly sorb suture used as well, to provide traction.Beginning with a spectranetics 11f tightrail rotating dilator sheath, the lead high voltage cables began to externalize; therefore, the device was upsized to a 13f tightrail sub-c, to accommodate the damaged lead.Once the sub-c had successfully advanced and ran out of length, a 13f tightrail (long) was used.Several binding sites were encountered within the vasculature, but progress was made to approximately 1/3 of the way down the lead second coil.However, the patient's blood pressure dropped.Rescue efforts began, including rescue balloon, cpr, administration of blood products and fluids, sternotomy, and cell saver.A superior vena cava (svc)/ra junction perforation was discovered and repaired.Despite repair with approximately 45 minutes of life saving efforts, the patient did not survive.This report captures the 13f tightrail in use in the area when the perforation occurred, requiring intervention but resulting in death.There was no alleged malfunction of any spectranetics devices in use during the procedure.

• Brand Name: TIGHTRAIL ROTATING DILATOR SHEATH
• Common Device Name: 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 ; 719447-2465
• MDR Report Key: 20611531
• Report Number: 3007284006-2024-00223
• Device Sequence Number: 15306347
• Product Code: DRE
• UDI-Device Identifier: 00813132021658
• UDI-Public: (01)00813132021658(17)260801(10)FRJ24H01A
• Combination Product (Y/N): N
• 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): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/05/2024

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: 08/01/2026
• Device Model Number: 545-513
• Device Catalogue Number: 545-513
• Device Lot Number: FRJ24H01A
• 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: 10/28/2024
• Initial Report FDA Received Date: 11/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2024
• 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: BOSTON SCIENTIFIC 0276/64 RV ICD LEAD; BOSTON SCIENTIFIC 7741/52 RA PACING LEAD; POLYSORB SUTURE FOR TRACTION, MANUFACTURER UNK; SPECTRANETICS 11F TIGHTRAIL DILATOR SHEATH; SPECTRANETICS 13F TIGHTRAIL SUB-C DILATOR SHEATH; SPECTRANETICS LLD EZ LEAD LOCKING DEVICE
• Outcome Attributed to Adverse Event: Death; Life Threatening
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White