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

Model Number	518-022
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Great Vessel Perforation (2152); Iatrogenic Source (2498); Atrial Perforation (2511)
Date of Event	06/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient date of birth unavailable.
Event or Problem 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 lld, present within and providing traction for extraction of the ra lead, at the time of the atrial injury.The svc injury is captured in mdr #1721279-2020-00144, involving use of the glidelight device in the area of the svc.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Common Device Name: STYLET, CATHETER
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 10311671
• Report Number: 1721279-2020-00145
• Device Sequence Number: 19644972
• Product Code: DRB
• UDI-Device Identifier: 00813132023027
• UDI-Public: (01)00813132023027(17)201019(10)FLD18K17A
• Combination Product (Y/N): Y
• Initial Reporter Country: FR
• PMA/510(K) Number: K990713
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/25/2020
• Report Date (Section F): 01/01/2005

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/19/2020
• Device Model Number: 518-022
• Device Catalogue Number: 518-022
• Device Lot Number: FLD18K17A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2020
• Initial Report FDA Received Date: 07/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 80 YR
• Patient Weight: 71
• Date Report Sent to FDA: 01/01/2005