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 Iatrogenic Source (2498); Atrial Perforation (2511)

Event Date 09/29/2020

Event Type  Injury  

Manufacturer Narrative

Patient's date of birth unavailable.Patient's weight unavailable.Device model number, lot number, expiration date and udi unavailable.Device manufacture date unavailable because lot number unavailable.

Event Description

A lead extraction procedure commenced to remove two leads, a right ventricular (rv) lead and a right atrial (ra) lead due to non function.Spectranetics lead locking devices (lld ez's) were inserted into each lead to act as a traction platform to aid in extraction.Using a glidelight laser sheath, the physician successfully extracted the ra and rv leads.However, after the rv lead was removed, the patient's blood pressure gradually declined.Transesophageal echocardiography (tee) image showed a pericardial effusion.Rescue efforts began immediately, including rescue balloon and sternotomy.A 2-2.5cm tear was discovered at the junction of the ra and the ra appendage.The repair was successful and the patient survived the procedure.The physician was uncertain how the injury occurred; however the two possibilities was the lead tip freeing up from its attachment point, or possibly the laser sheath.However it is unlikely to be caused by the laser sheath because it was reported that the laser sheath was never used in the area of the injury.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: 10692423
• MDR Text Key: 215057954
• Report Number: 1721279-2020-00211
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K142116
• 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: 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2020
• 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: UNVAILABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 51 YR