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); Pericardial Effusion (3271)
Date of Event	09/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B6/b7): patient information regarding relevant tests/laboratory data or medical history are unk.H3): the 13f tightrail was not returned, thus no returned product investigation was performed.H6): great vessel perforation 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 two right ventricular (rv) leads (one abandoned and one active) due to lead damage and a redundant lead.Spectranetics lld #2 lead locking devices (lld #2s) were inserted into each lead to provide traction; however, the lld #2 in the abandoned lead advanced only to the area of lead damage and became stuck, but was able to be used, despite not being deployed.Using spectranetics devices (16f glidelight laser sheath and 13f tightrail rotating dilator sheath), the active rv lead was successfully removed.Then, while working to remove the abandoned rv lead with use of the 13f tightrail, the patient's blood pressure dropped and a pericardial effusion was detected.Rescue efforts began, including pericardiocentesis.The patient had a cardiac arrest (blood coagulated in a strange way) and a sternotomy followed; a perforation in the superior vena cava (svc) was discovered and repaired.The abandoned rv lead was cut (with the lld #2 being removed in its entirety), with the lead remnant remaining in the patient, and the patient survived the procedure.This report captures the 13f tightrail in use 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: 20359715
• Report Number: 3007284006-2024-00200
• Device Sequence Number: 7199835
• Product Code: DRE
• UDI-Device Identifier: 00813132021658
• UDI-Public: (01)00813132021658(17)260326(10)FRJ24C26A
• 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): 10/03/2024

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: 03/26/2026
• Device Model Number: 545-513
• Device Catalogue Number: 545-513
• Device Lot Number: FRJ24C26A
• 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: 09/25/2024
• Initial Report FDA Received Date: 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/26/2024
• 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 SPRINT FIDELIS RV ICD LEAD; PHILIPS LASER SYSTEM; RV ICD LEAD, MANUFACTURER/MODEL UNK; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH; SPECTRANETICS LLD #2 LEAD LOCKING DEVICES
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic