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 Great Vessel Perforation (2152); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 10/07/2022

Event Type  Death  

Manufacturer Narrative

The device was discarded, thus no investigation could be completed.Vessel and cardiac perforations are known risks 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 previously cut and capped right ventricular (rv) lead due to non function and redundancy.The patient had a bilateral system present: the targeted rv lead and an active right atrial (ra) lead were implanted from a left chest access, and an inactive rv lead and a left ventricular (lv) lead were implanted from a right chest access, with the leads then tunneled to the left side for connection to one generator, present in the patient's left chest.The other three leads were not initially targeted for extraction.A spectranetics lead locking device (lld) was inserted into the targeted rv lead to provide traction.Using a spectranetics 16f glidelight laser sheath, the rv lead was successfully extracted.The physician chose to remove the ra lead as well.An lld was inserted into the ra lead and the physician used the 16f glidelight, advancing to approximately one inch from the lead's distal tip.The patient's blood pressure dropped and rescue efforts began immediately, including rescue balloon, blood administration, and pericardiocentesis.The patient's blood pressure was treated with medications but then dropped again, and a sternotomy was performed.A 3 cm perforation was discovered in the superior vena cava (svc)/ra junction, on the anterior wall of the vessel.The physician felt that with traction forces, the lead pulled away from the vessel wall due to the adhered scar tissue present in the region.The perforation originated on the anterior side of the vessel, where the glidelight's distal tip was not present.The perforation was repaired; however, after multiple shocks to the heart afterwards, the patient did not survive.This report captures the lld providing traction to the ra lead when the svc/ra junction perforation occurred, requiring intervention but resulting in death.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
• MDR Report Key: 15677500
• MDR Text Key: 302465697
• Report Number: 1721279-2022-00185
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023072
• UDI-Public: (01)00813132023072(17)240312(10)FLP22B24A
• 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: 10/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/12/2024
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP22B24A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2022
• 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: BOSTON SCIENTIFIC 0144-64 RV PACING LEAD (L).; BOSTON SCIENTIFIC 432-04 RA PACING LEAD.; MEDTRONIC 4193-88 LV LEAD.; MEDTRONIC 6947-65 RV PACING LEAD (R).; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH.; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM.; SPECTRANETICS LEAD LOCKING DEVICE IN RV LEAD.
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 71 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White