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

Model Number	545-511
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pleural Effusion (2010); Perforation of Vessels (2135); Great Vessel Perforation (2152)
Date of Event	02/10/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was discarded, thus no investigation could be completed.Although the tight rail device malfunctioned in the procedure (was unable to actuate after being used), the malfunction was unrelated to the perforation that occurred.
Event or Problem Description
A lead extraction procedure commenced to remove a right atrial (ra) and a right ventricular (rv) lead due to endocarditis (both leads originally implanted in 2010).A baseline effusion was noted prior to the case.Spectranetics lead locking devices (llds) were inserted into each lead and were used to provide traction; however neither lld reached the tips of the leads.The physician began by using a spectranetics 14f glidelight laser sheath to attempt removal of the ra lead.However, the device became stuck at the superior vena cava (svc)/ra junction and could not be retracted back.Several maneuvers were performed to free the glidelight device from the lead and eventually it freed (mdr #1721279-2022-00043).The physician then switched to a spectranetics 11f tight rail rotating dilator sheath to attempt extraction of the ra lead, which was successfully removed.Attempting rv lead removal, the tight rail device was advanced to approximately the same region as where the glidelight device became stuck.It was very difficult to make progress through this area.It was suggested to remove the tight rail device from the patient, flush it and test the blade mechanism.After noting that it appeared the tight rail device's blades weren't actuating, the physician decided to use a 13f tight rail device.However, after the device was opened and prepped but not used, an effusion was noted on transesophageal echocardiography (tee) that was larger than at baseline.The patient's blood pressure began to drop, then a complete loss of blood pressure occurred followed by a loss of heart rate.Rescue efforts began immediately, including initiating cpr, alerting the surgeon, administering blood, and using rescue balloon.When the surgeon arrived, cpr was withdrawn, and it was noted the patient had a blood pressure and a heart rhythm.Interventions continued, including holding pressure due to bleeding at the pacemaker pocket, checking again for effusion (none present), withdrawing rescue balloon, observing patient, and performing multiple venograms.There were no obvious signs of a perforation in the svc or innominate veins, but there was a small area of staining within the svc, which the surgeon believed could be a perforation of the azygos vein.The patient remained stable and the physician chose to abandon the rv lead within the patient.The physician did not attempt to unlock the lld and remove it from the rv lead prior to cutting the lead, so the rv lead with the lld contained within the lead were both cut, capped and remained in the patient (mdr #1721279-2022-00044).The patient survived the procedure.This report captures the 11f tight rail device in use when the svc/azygos perforation occurred.The malfunction of this device, in which the blades did not actuate during the procedure, is unrelated to the perforation that occurred.

• Brand Name: SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921
• MDR Report Key: 13690936
• Report Number: 1721279-2022-00045
• Device Sequence Number: 20111457
• Product Code: DRE
• UDI-Device Identifier: 00813132021641
• UDI-Public: (01)00813132021641(17)231202(10)FRK21M01A
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/10/2022

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: 12/02/2023
• Device Model Number: 545-511
• Device Catalogue Number: 545-511
• Device Lot Number: FRK21M01A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2022
• Initial Report FDA Received Date: 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2021
• 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 5076 RV PACING LEAD; MEDTRONIC 5568 RA PACING LEAD; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LEAD LOCKING DEVICES
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 88 YR
• Patient Sex: Female
• Patient Weight: 101 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White