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

Model Number	545-509
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	08/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A2: patient date of birth unknown.B6/b7: patient information regarding relevant tests/laboratory data or medical history are unknown.H3: the tightrail was not returned, thus no returned product investigation was performed.H6: perforation of vessels is a known risk 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 atrial (ra) and a right ventricular (rv) lead due to non function.Spectranetics lld ez lead locking devices (lld ezs) were inserted into each lead to provide traction.Using a spectranetics 9f tightrail rotating dilator sheath, the rv lead was removed first, then the ra lead.When the tightrail was removed, a subclavian perforation was detected, resulting in a large loss of blood to the patient.A rescue balloon was used to temporarily occlude the perforation, followed by placement of 3 stents to repair the perforation.The patient survived the procedure.This report captures the tightrail in use within the area when the perforation occurred, requiring intervention.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: 20141591
• Report Number: 3007284006-2024-00182
• Device Sequence Number: 3226880
• Product Code: DRE
• UDI-Device Identifier: 00813132021634
• UDI-Public: (01)00813132021634(17)260131(10)FRH24A30A
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/04/2024

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: 01/31/2026
• Device Model Number: 545-509
• Device Catalogue Number: 545-509
• Device Lot Number: FRH24A30A
• 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: 08/14/2024
• Initial Report FDA Received Date: 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/30/2024
• 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: ABBOTT TENDRIL RA PACING LEAD, MODEL NUMBER UNK.; ABBOTT TENDRIL RV PACING LEAD, MODEL NUMBER UNK.; SPECTRANETICS LLD EZ LEAD LOCKING DEVICES.
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 45 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White