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

Model Number UNAVAILABLE

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

Patient Problems Death (1802); Iatrogenic Source (2498); Cardiac Perforation (2513)

Event Date 10/20/2020

Event Type  Death  

Manufacturer Narrative

Device model number, lot number, expiration date and udi unavailable.Device 510k number unavailable because model number unavailable.Device manufacture date unavailable because lot number unavailable.

Event Description

A lead extraction procedure commenced to remove a right ventricular (rv) and a left ventricular (lv) lead due to bacteremia.The patient had a complex medical history and comorbidities.Spectranetics lead locking devices (lld's) were placed within each lead to provide traction during extraction.It was reported that the lv lead was removed.The physician chose to use a 13f tightrail rotating dilator sheath and while working to remove the rv lead, the tightrail device was in the innominate region, and the rv lead seemed to release, as it pulled back into the outer sheath repeatedly a few centimeters with no advancement of the outer sheath.While fluoroscopy was in use to check the location of the rv lead tip, the patient's blood pressure was discovered to be low.Traction was released from the rv lead, but blood pressure did not recover.The blood pressure was then treated by anesthesia and rescue efforts began, including rescue balloon, pericardiocentesis and sternotomy.An injury to the patient's right ventricle was discovered.The surgeon continued attempt of the repair of the injury but was not successful.The patient passed away.The patient was given blood products throughout the rescue but did not go on pump as it was decided the patient's heart with its already poor condition with very low output to begin with, that it would not have helped.There was no alleged malfunction of any spectranetics device 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 Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 10833419
• MDR Text Key: 216077057
• Report Number: 1721279-2020-00231
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNAVAILABLE
• Device Catalogue Number: UNAVAILABLE
• Device Lot Number: UNAVAILABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 64 YR
• Patient Weight: 148