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

Model Number 518-062

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/25/2022

Event Type  Injury  

Manufacturer Narrative

Patient''s weight unk.Relevant tests/laboratory data unk.Other relevant history unk.A portion of the device was discarded and a portion remained in the patient, thus no investigation could be completed.Device damage, damage to targeted lead, and cut and cap are known risks of complication with use of the lld.The device was not returned; therefore a cause of the reported failure could not be established.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) lead due to low impedance.Right ventricular (rv) and left ventricular (lv) leads were present in the patient as well, but were not targeted for extraction.Lead insulation abrasion was noted near the pocket, and a spectranetics lead locking device (lld) was inserted into the ra lead to provide traction.The physician used multiple spectranetics devices (12f glidelight laser sheath, tightrail rotating dilator sheath) to attempt the lead extraction.As traction was applied, the lld broke along with the ra lead (location of break unk).The physician then attempted lead extraction using a cook medical bulldog lead extender, abbott stylets and fiber tape, but was unsuccessful.The ra lead and lld were cut and capped and remained in the patient.The patient survived the procedure.This report captures the lld which broke along with the ra lead, requiring intervention to attempt lead removal, but 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: 15776008
• MDR Text Key: 303543555
• Report Number: 1721279-2022-00198
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023072
• UDI-Public: (01)00813132023072(17)240927(10)FLP22J23A
• 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: 11/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Device Lot Number: FLP22J23A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/25/2022
• Initial Date FDA Received: 11/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2022
• 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: ABBOTT 2088TC-52 RA PACING LEAD; ABBOTT LV LEAD MODEL UNK; BOSTON SCIENTIFIC RV ICD LEAD MODEL UNK; SPECTRANETICS 12F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American