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

Model Number 540-011

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

Patient Problems Great Vessel Perforation (2152); Pericardial Effusion (3271)

Event Date 09/29/2023

Event Type  Injury  

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 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
• 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: 17992728
• MDR Text Key: 326350268
• Report Number: 3007284006-2023-00046
• Device Sequence Number: 1
• Product Code: DRE
• UDI-Device Identifier: 00813132021627
• UDI-Public: (01)00813132021627(17)250616(10)FRM23F16A
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2023
• 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: 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
• Patient Outcome(s): 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