MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS

Model Number 500-302

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

Patient Problems Great Vessel Perforation (2152); Iatrogenic Source (2498); Atrial Perforation (2511)

Event Date 06/25/2020

Event Type  Injury  

Manufacturer Narrative

Patient's date of birth unavailable.

Event Description

A lead extraction procedure commenced to remove two leads: a right atrial (ra) and right ventricular (rv) lead due to infection.A lead locking device (lld) was inserted into each lead to act as a traction platform to aid in extraction.Using a spectranetics glidelight laser sheath, the physician removed the rv lead without difficulty.However, after extraction of the ra lead, the patient's blood pressure dropped.Rescue efforts began immediately, including pericardiocentesis and sternotomy.Injuries to the atrium and to the posterior superior vena cava (svc) were discovered.These areas were repaired successfully, epicardial leads were used to stimulate the heart, and the patient survived the procedure.This report captures the glidelight, used within the svc during the procedure in the area of the injury.The atrial injury is captured in mdr #1721279-2020-00145, involving use of the lld.

• Brand Name: SPECTRANETICS 14F 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: 10311667
• MDR Text Key: 200073254
• Report Number: 1721279-2020-00144
• Device Sequence Number: 1
• Product Code: MFA
• UDI-Device Identifier: 00813132020330
• UDI-Public: (01)00813132020330(17)210612(10)FGB19F07A
• Combination Product (y/n): Y
• Reporter Country Code: FR
• 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: 01/01/2005,06/25/2020

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 Expiration Date: 06/12/2021
• Device Model Number: 500-302
• Device Catalogue Number: 500-302
• Device Lot Number: FGB19F07A
• 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
• Initial Date Manufacturer Received: 06/25/2020
• Initial Date FDA Received: 07/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2019
• 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: 80 YR
• Patient Weight: 71