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

Model Number 518-067

Device Problem Break (1069)

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

Event Date 11/08/2022

Event Type  Injury  

Manufacturer Narrative

The device was discarded, thus no investigation could be completed.Although device damage is a known risk of complication with use of the lld, the cause for the lld breaking 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 ventricular (rv) and a right atrial (ra) lead, extraction indication unk.Spectranetics lead locking devices (llds) were inserted into each lead to provide traction.The physician began by using a spectranetics 14f glidelight laser sheath to attempt removal of the rv lead.Progress stalled around the subclavian vein, and the physician pushed the 14f glidelight to assess if it was advancing; however, no progress was noted.At that time, the lld within the rv lead broke outside the patient''s body at the front side of the locking mechanism (mdr #1721279-2022-00219).The 14f glidelight was stuck on the rv lead, so the physician inserted a cook needle''s eye snare from a right femoral approach, capturing the rv lead while he successfully pulled the 14f glidelight from the patient (mdr #1721279-2022-00220).However, when the 14f glidelight was examined outside the patient''s body, it was noted that it was broken on the working length, just distal to the bifurcate handle (mdr #1721279-2022-00220).The physician switched efforts to attempt removal of the ra lead.A cook 11f evolution mechanical dilator sheath and a green cook byrd dilator sheath were used, along with the lld providing traction.However, the ra lead broke at its ring tip, and the tip required removal using the needle''s eye snare (mdr #1721279-2022-00221).The physician again attempted removal of the rv lead by using a green byrd sheath, a white byrd sheath, an 11f evolution, and suture for traction.It was noted that the rv lead''s outer coating was torn in the area of the subclavian vein, so he upsized to a 16f glidelight.The rv lead broke in the middle of the lead (mdr #1721279-2022-00222); therefore, the physician chose to remove the rv lead remnant from a right femoral approach by utilizing a cook 18f check-flo introducer sheath.Then, the 16f glidelight was inserted through the check-flo sheath, and the needle''s eye snare was inserted through the inner lumen of the 16f glidelight.The 16f glidelight was lasing within the inferior vena cava (ivc) in an effort to free the tip of the lead when the patient''s blood pressure dropped.Rescue efforts began immediately, including sternotomy, and an ivc perforation was discovered (mdr #1721279-2022-00222).Repair of the ivc was successful, the rv lead was removed, and the patient survived the procedure.This report captures the lld in the rv lead which broke, requiring intervention.

• 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: 15936132
• MDR Text Key: 305045965
• Report Number: 1721279-2022-00219
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023065
• UDI-Public: (01)00813132023065(17)240629(10)FLK22F03A
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K142116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 518-067
• Device Catalogue Number: 518-067
• Device Lot Number: FLK22F03A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2022
• 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: BIOTRONIK LINOXSMART S65 RV ICD LEAD; COOK MEDICAL 11F EVOLUTION DILATOR SHEATH; COOK MEDICAL CHECK-FLO INTRODUCER SHEATH; COOK MEDICAL GREEN BYRD DILATOR SHEATH; COOK MEDICAL NEEDLE'S EYE SNARE; COOK MEDICAL WHITE BYRD DILATOR SHEATH; MEDTRONIC 5554/53 RA PACING LEAD; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LEAD LOCKING DEVICE IN RA LEAD
• Patient Outcome(s): Required Intervention
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian