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 Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/02/2022

Event Type  Injury  

Manufacturer Narrative

A portion of the device was discarded and a portion remained in the patient, thus no investigation could be completed.Although lld cut/cap is a known risk of complication with the lld, the physician did not attempt to unlock the lld from the rv lead prior to cutting and capping.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 non-function.The rv lead''s tip had migrated into the right atrium (ra) and had externalized, adhering to the region at the inferior vena cava (ivc)/ra junction, with heavy calcification present.A spectranetics lead locking device (lld) was inserted into the lead to provide traction.The physician began the extraction attempt by using a spectranetics 16f glidelight laser sheath.Advancement was made up to the point of externalization of the lead, but the patient''s blood pressure dropped.Rescue efforts began immediately, including pericardiocentesis and sternotomy.A 3 cm inferior vena cava (ivc)/ra junction perforation was discovered (mdr #1721279-2022-00207).The perforation was repaired; however, the extraction attempt did not continue.The physician cut and capped the rv lead, along with the lld (which he did not attempt to unlock) (mdr #1721279-2022-00208), due to concern for putting patient at further risk.The patient survived the procedure, and has since been discharged from the hospital.This report captures the lld present in the rv lead when it was cut, capped and remained in the patient.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: 15840633
• MDR Text Key: 304081405
• Report Number: 1721279-2022-00208
• 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: 11/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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 the Report Sent to FDA?: No
• Date Manufacturer Received: 11/02/2022
• 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 7000 RV ICD LEAD; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
• Patient Outcome(s): Other
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Weight: 99 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American