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

Model Number 560-013

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

Patient Problem Perforation of Vessels (2135)

Event Date 11/07/2023

Event Type  Death  

Manufacturer Narrative

H3): the device was discarded, thus no investigation could be completed.H6): perforation of vessels and death are known risks of complication with use of the tightrail sub-c 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) and a right ventricular (rv) lead due to cied system/pocket infection.The patient was elderly and frail, and had a grossly infected right sided pocket, which was medically managed since july 2023.Both a spectranetics lead locking device and a cook medical bulldog lead extender were used as traction platforms (it is unk which device was used on which lead).Multiple spectranetics devices (glidelight laser sheath, visisheath dilator sheath, tightrail rotating dilator sheath, tightrail 13f sub-c rotating dilator sheath, and tightrail mini rotating dilator sheath) were used during the procedure.Efforts began to extract the ra lead first; however, stalled progress was encountered.The patient''s blood pressure fluctuated throughout the extraction attempt, but the procedure continued.Next, the tightrail 13f sub-c was used to attempt removal of the rv lead, but the patient''s blood pressure dropped.Rescue efforts began immediately, including rescue balloon, bypass, and sternotomy.A right innominate perforation was discovered, and although extensive efforts were made to surgically repair the area, the patient did not survive.This report captures the tightrail sub-c, the last device in use in the area when the perforation occurred, requiring intervention but resulting in death.There was no alleged malfunction of any spectranetics devices in use during the procedure.

• Brand Name: TIGHTRAIL SUB-C 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: 18248984
• MDR Text Key: 329507325
• Report Number: 3007284006-2023-00080
• Device Sequence Number: 1
• Product Code: DRE
• UDI-Device Identifier: 00813132022808
• UDI-Public: (01)00813132022808(17)250620(10)FRQ23F20A
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161333
• 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: 12/01/2023

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: 560-013
• Device Catalogue Number: 560-013
• Device Lot Number: FRQ23F20A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2023
• 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: ABBOTT 1882TC/46 RA PACING LEAD.; ABBOTT 1882TC/52 RV PACING LEAD.; COOK MEDICAL BULLDOG LEAD EXTENDER.; SPECTRANETICS 13F TIGHTRAIL SUB-C DILATOR SHEATH.; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM.; SPECTRANETICS GLIDELIGHT LASER SHEATH.; SPECTRANETICS LEAD LOCKING DEVICE.; SPECTRANETICS TIGHTRAIL MINI DILATOR SHEATH.; SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH.; SPECTRANETICS VISISHEATH DILATOR SHEATH.
• Patient Outcome(s): Death; Life Threatening; Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White