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

Model Number 518-062

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/03/2022

Event Type  Injury  

Manufacturer Narrative

The device was discarded, thus no investigation could be completed.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 in an or lab to remove a right ventricular (rv) lead due to pocket infection.A spectranetics lead locking device (lld) was inserted into the lead to provide traction; suture was also tied to the proximal end of the lead/lld for additional traction.The physician chose a spectranetics 14f glidelight laser sheath to begin the extraction, with stalled progress occurring just before the innominate/superior vena cava (svc) junction.The physician then used a spectranetics 11f tightrail rotating dilator sheath and some progress was made, but stalled as well.The physician switched back and forth between the 14f glidelight and the 11f tightrail, and was able to progress to the lead''s icd coil, around the tricuspid valve but progress stalled again.During selection of another device, the lld disengaged from the lead and broke, with the suture breaking, but the rv lead did not break.Intervention was required to attempt to gain another traction platform.Preparation of the lead was attempted with suture only, but control of the lead could not be regained without the suture breaking.After deliberation, the physician decided to abandon the extraction due to the inability to create a safe traction platform.The physician cut the rv lead (cut portion contained remnant of lld, no lld remained within the patient) and allowed the rv lead to retract into body (retained in patient).The patient survived the procedure, and came back to the lab for pocket drainage prior to discharge.This report captures the lld providing traction to the rv lead that broke, requiring intervention to attempt lead removal.

• 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: 14880321
• MDR Text Key: 295124136
• Report Number: 1721279-2022-00126
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023072
• UDI-Public: (01)00813132023072(17)231214(10)FLP21M3A
• 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: 06/30/2022

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 Expiration Date: 12/14/2023
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP21M13A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/03/2022
• Initial Date FDA Received: 06/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2021
• 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 0293 RV ICD LEAD; SPECTRANETICS 11F TIGHTRAIL DILATOR SHEATH; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS LEAD LOCKING DEVICE; SUTURE TO PROVIDE TRACTION MANUFACTURER UNK
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 112 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American