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

Model Number	540-011
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	09/29/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3): the device was discarded, thus no investigation could be completed.H6): this event has been determined to be use error/failure to follow instructions.The physician used the tightrail mini to advance into the svc when the perforation occurred.Per the ifu, it states: do not attempt to enter the svc structure or attempt to navigate the tightrail mini sheath into bends beyond the convergence of the innominate and brachiocephalic veins as vessel wall or cardiac lead damage may occur.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 the other one active and lumenless) for an upgrade to a crt-d system.A right atrial (ra) lead was also present in the patient, but was not targeted for extraction.A spectranetics lead locking device (lld ez) was inserted into the abandoned rv lead to provide traction.Beginning with a spectranetics 14f glidelight laser sheath and a spectranetics medium visisheath dilator sheath, progress stalled in the innominate region.Then, a spectranetics 11f tightrail mini rotating dilator sheath was used to progress slowly into the superior vena cava (svc), with advancement being difficult due to tight space within the vasculature.The patient''s blood pressure dropped and transesophageal echocardiography (tee) confirmed the presence of a pericardial effusion.Rescue efforts began, including rescue balloon and sternotomy.A small (approximately 1-1 1/2 cm) svc lateral wall perforation was discovered and repaired.After repair was completed, a 13f tightrail was used post-sternotomy to attempt removal of the abandoned rv lead.However, when the tightrail advanced to the area of injury, the perforation re-opened.The patient was placed on pump, and after the perforation was repaired again, the surgeon cut the binding that was adhering the rv lead to the vasculature, and the rv lead/lld were successfully removed.The active rv lead was not removed as initially planned.Epicardial leads were placed, and the patient survived the procedure.This report captures the 11f tightrail mini in use within the svc when the initial perforation occurred, requiring intervention.There was no alleged malfunction of any spectranetics devices in use during the procedure.

• Brand Name: TIGHTRAIL MINI 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: 17992728
• Report Number: 3007284006-2023-00046
• Device Sequence Number: 7548764
• Product Code: DRE
• UDI-Device Identifier: 00813132021627
• UDI-Public: (01)00813132021627(17)250616(10)FRM23F16A
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/23/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/16/2025
• Device Model Number: 540-011
• Device Catalogue Number: 540-011
• Device Lot Number: FRM23F16A
• 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: Not provided
• Initial Report FDA Received Date: 10/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2023
• 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 3830 ACTIVE LUMENLESS RV PACING LEAD; MEDTRONIC 5076 ABANDONED RV PACING LEAD; MEDTRONIC 5076 RA PACING LEAD; SPECTRANETICS 13F TIGHTRAIL DILATOR SHEATH; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LEAD LOCKING DEVICE (LLD EZ); SPECTRANETICS MEDIUM VISISHEATH DILATOR SHEATH
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American