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

Model Number 545-513

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

Patient Problem Great Vessel Perforation (2152)

Event Date 03/08/2024

Event Type  Injury  

Manufacturer Narrative

H3: the device was discarded, thus no investigation could be completed.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 Description

A lead extraction procedure commenced to remove a right atrial (ra), a right ventricular (rv) and a left ventricular (lv) lead due to cied system/pocket infection.Spectranetics lead locking devices (llds) were inserted into each lead to provide traction.Beginning with a spectranetics 12f glidelight laser sheath on the lv lead, the lead was successfully removed.Next, snares were used from a femoral approach on the ra and rv leads to provide additional traction.Then, a 16f glidelight was used to alternate between the leads, but progress stalled in the clavicle.Switching to a spectranetics 13f tightrail rotating dilator sheath and alternating between leads, progress was achieved down the vasculature.A small effusion was noted via transesophageal echocardiography (tee), but initially, there was no change in the patient''s blood pressure.However, during the last attempt to remove the ra lead and while the tip of the tightrail was in the superior vena cava (svc), a larger anterior effusion was detected.When the tightrail was pulled back into the innominate region, the patient''s blood pressure dropped.Rescue efforts began immediately, including rescue balloon, pump, and sternotomy.An svc perforation was discovered and repaired.The ra and rv leads were removed post-sternotomy.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
• 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: 19046553
• MDR Text Key: 339430702
• Report Number: 3007284006-2024-00068
• Device Sequence Number: 1
• Product Code: DRE
• UDI-Device Identifier: 00813132021658
• UDI-Public: (01)00813132021658(17)251219(10)FRJ23M19A
• 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: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 545-513
• Device Catalogue Number: 545-513
• Device Lot Number: FRJ23M19A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2023
• 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: BIOTRONIK 408719 LV LEAD.; BOSTON SCIENTIFIC 0154 RV PACING LEAD.; BOSTON SCIENTIFIC 4243 RA PACING LEAD.; FEMORAL SNARES MANUFACTURER/TYPE UNK.; SPECTRANETICS 12F GLIDELIGHT LASER SHEATH.; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH.; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM.; SPECTRANETICS LEAD LOCKING DEVICES.
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 49 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White