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

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/26/2022

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr: a portion of the device was discarded and a portion remained in the patient, thus no investigation could be completed.Lld cut and cap is a known risk of complication with use of the lld device.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 failed right atrial (ra) and externalized right ventricular (rv) leads.Present within the patient were two other leads: a left ventricular (lv) lead, externalized but functioning normally, and a functional rv lead.The patient was pacemaker dependent; in addition, the patient's subclavian vein was occluded where the failed rv lead had externalized.Given the age of the patient (32 years old) and the dwell time of the leads (16 years), it was planned that the 2 failed leads would be extracted as a priority and the other two would be considered for removal, dependent on case progression and complexity.Spectranetics lead locking devices (llds) were inserted into the failed ra and rv leads to provide traction.The physician used a spectranetics 16f glidelight laser sheath on the rv lead, anticipating lead snowplow (lead bunching up), as well as getting over the externalization.Advancement was made to the innominate vein, where progress stalled due to lead on lead binding.Physician switched to attempt extraction of the ra lead with the glidelight, and made progress past the innominate vein to the superior vena cava (svc)/ra junction, where another binding site was encountered.The physician then removed the glidelight to again attempt removal of the rv lead, when the patient''s blood pressure dropped.A cardiac tamponade was confirmed via trans-oralesophageal echocardiography (toe).Rescue efforts began, including rescue balloon, bypass, and sternotomy.A 1-2 cm svc/ra junction perforation was discovered, along with a 1-2 cm innominate perforation (mdr #1721279-2022-00199) and repairs were successful.Rv lead (mdr #1721279-2022-00201) were not removed; the physician attempted to unlock the llds from the leads but was unsuccessful so the llds within the leads were cut and capped and remained in the patient.No leads were removed during this event; epicardial leads were implanted and the patient was taken to recovery in stable condition, surviving the procedure.This report captures the lld present in the ra lead which was cut and capped and remained in the patient.

• 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: 15776702
• MDR Text Key: 303557122
• Report Number: 1721279-2022-00200
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/26/2022
• 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: ABBOTT 1688T FAILED RA PACING LEAD.; ABBOTT OPTIFLEX 1156T LV PACING LEAD.; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH.; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM.; SPECTRANETICS LEAD LOCKING DEVICE.; ST. JUDE MEDICAL RIATA 1582 FAILED RV ICD LEAD.; ST. JUDE MEDICAL TENDRIL 1688T RV PACING LEAD.
• Patient Outcome(s): Other
• Patient Age: 32 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White