MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS LEAD LOCKING DEVICE; STYLET, CATHETER

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

Patient Problem Cardiac Perforation (2513)

Event Date 06/30/2022

Event Type  Injury  

Manufacturer Narrative

Patient''s date of birth, age unk.Patient''s weight unk.Patient''s ethnicity/race unk.Relevant tests/laboratory data unk.Other relevant history unk.Device model number, lot number, catalog number, expiration date and udi unk.Device 510k number unk because model number unk.The device was discarded, thus no investigation could be completed.Device manufacture date unk because lot number unk.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 ventricular (rv) lead due to bacteremia.There were three other leads present within the patient, but unk if leads were targeted for extraction.A spectranetics lead locking device (lld) was inserted into the rv lead to provide traction.When traction was being applied by the lld along with use of a spectranetics tightrail rotating dilator sheath, a right ventricular (rv) avulsion occurred.Rescue efforts began, including rescue balloon and thoracotomy.An rv perforation was discovered and was successfully repaired.However, the patient contracted covid in itu and died of multiple organ failure 15 days post procedure.This report captures the lld providing traction in the rv lead when the rv perforation occurred, which required intervention.Although the patient died 15 days post procedure, the death was unrelated to the procedure.There was no alleged malfunction of the lld in use during the procedure.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: STYLET, CATHETER
• 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: 15226296
• MDR Text Key: 297910200
• Report Number: 1721279-2022-00148
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: RV LEAD MANUFACTURER MODEL AND TYPE UNK; SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Sex: Male