MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS GLIDELIGHT LASER SHEATH; DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS

Model Number UNAVAILABLE

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

Patient Problems Great Vessel Perforation (2152); Iatrogenic Source (2498)

Event Date 07/01/2020

Event Type  Injury  

Manufacturer Narrative

Patient weight unavailable.Device model, lot number, expiration date and udi unavailable from facility.Device manufacture date unavailable because device lot number unavailable.

Event Description

A philips representative received word that a lead extraction procedure commenced to remove a right atrial (ra), right ventricular (rv) and left ventricular (lv) lead due to infection.Although details are limited and have been difficult to obtain, it was reported that a spectranetics glidelight laser sheath was in use (model and lot number of the device unavailable).During the procedure, the patient suffered a superior vena cava (svc) tear within the pericardial space.This resulted in immediate tamponade and a cardiac arrest.Rescue efforts commenced immediately upon discovery of the injury.A sternotomy was performed, the repair of the svc injury was successful and the patient survived the procedure.It was reported that there was no malfunction of the glidelight device during the procedure.This report is being submitted because the glidelight was reportedly in use in the area of injury during the procedure.

• Brand Name: SPECTRANETICS GLIDELIGHT LASER SHEATH
• Type of Device: DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
• 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: 10320467
• MDR Text Key: 200784918
• Report Number: 1721279-2020-00149
• Device Sequence Number: 1
• Product Code: MFA
• Combination Product (y/n): Y
• Reporter Country Code: UK
• PMA/PMN Number: P960042
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,07/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2020
• 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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 07/02/2020
• 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: 67 YR