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

Model Number 518-062

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

Patient Problems Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 04/12/2023

Event Type  Injury  

Manufacturer Narrative

B6): relevant tests/laboratory data unk.D4): device lot number, expiration date unk.H3): the device was discarded, thus no investigation could be completed.H4): device manufacture date unk because lot number unk.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.

Event Description

A lead extraction procedure commenced to remove a right atrial (ra) and a right ventricular (rv) lead due to non function.Spectranetics lead locking devices were inserted into each lead to provide traction.A spectranetics 14f glidelight laser sheath was used to begin extraction of the ra lead first, encountering stalled progression at the innominate/superior vena cava (svc) junction.Switching to the rv lead with the glidelight, progress stalled in the same area.Suspecting calcium was present in the vessel, a spectranetics 11f tightrail rotating dilator sheath was used on the rv lead, advancing only slightly.Switching back to the ra lead with the tightrail, the ra lead was removed; however, the patient''s blood pressure dropped immediately.Rescue efforts began, including chest compressions, rescue balloon, pericardiocentesis, and sternotomy.An ra perforation was discovered and repaired.The rv lead was then successfully extracted with use of the tightrail.The patient survived the procedure.This report captures the lld providing traction to the ra lead when the perforation occurred, requiring intervention.There was no alleged malfunction of any spectranetics devices 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 (Section G): SPECTRANETICS; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 16864918
• MDR Text Key: 314509135
• Report Number: 1721279-2023-00072
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023072
• UDI-Public: 00813132023072
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• 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
• Treatment: OSCOR P2744 RA PACING LEAD.; OSCOR P752 RV PACING LEAD.; SPECTRANETICS 11F TIGHTRAIL DILATOR SHEATH.; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH.; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM.; SPECTRANETICS LEAD LOCKING DEVICE IN RV LEAD.
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White