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

Model Number 518-062

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

Patient Problems Cardiac Tamponade (2226); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 08/10/2023

Event Type  Injury  

Manufacturer Narrative

A2): patient''s date of birth unk.A4): patient''s weight unk.H3): the device was discarded, thus no investigation could be completed.H6): cardiac perforation is a known risk of complication with use of the lld.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 ventricular (rv) lead due to lead failure.A spectranetics lead locking device (lld) was inserted into the lead, with suture being used as well, to provide traction.Using a spectranetics 14f glidelight laser sheath and the glidelight's outer sheath, stalled progress was encountered in the innominate region.A spectranetics 13f tightrail rotating dilator sheath was used next; however, no advancement was achieved due to either snowplowing of the lead (bunching up of the lead''s insulation), or the presence of scar tissue.The tightrail's outer sheath was added, but was not successful to advance.As another device was being selected to continue the extraction attempt, the patient's blood pressure dropped.Rescue efforts began immediately, including sternotomy.Cardiac tamponade was discovered and a large clot was pulled from the pericardial space.An rv perforation was suspected, but no injury was identified.The procedure was completed with use of a 16f glidelight to remove the rv lead, and the patient survived.The physician believed that pulling hard on the lead (with traction from the lld) caused an effusion at the lead tip, which resolved when traction was released.This report captures the lld providing traction within the rv lead when the suspected perforation occurred, requiring intervention.There was no alleged malfunction of any spectranetics devices in use during the procedure.

• Brand Name: LLD EZ LEAD LOCKING DEVICE
• Type of Device: STYLET, CATHETER
• Manufacturer (Section D): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): 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: 17652540
• MDR Text Key: 322310743
• Report Number: 3007284006-2023-00019
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 20813132023076
• UDI-Public: (01)20813132023076(17)250418(10)FLP23D13A
• 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: 08/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2023
• 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
• Device Lot Number: FLP23D13A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2023
• 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: MEDTRONIC 6935 RV ICD LEAD; SPECTRANETICS 13F TIGHTRAIL DILATOR SHEATH; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SUTURE MANUFACTURER/TYPE UNK
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic
• Patient Race: White