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 No Known Impact Or Consequence To Patient (2692)

Event Date 11/13/2020

Event Type  Injury  

Event Description

A philips representative reported that a lead extraction procedure commenced to extract a right ventricular (rv) implantable cardioverter defibrillator (icd) lead due to non function, and that the representative joined the case several hours after it had begun.Reportedly, a spectranetics lead locking device (lld) was inserted into the rv lead to provide traction and to aid in extraction.During the procedure, the lead broke proximal to the lead''s distal coil, and the lld pulled out of the lead in its entirety.It was reported that all spectranetics tools were out of the patient''s body and the physician stated all the tools worked correctly; that the lead breakage happens sometimes.The physician went on to femorally snare the lead with a cook medical needle''s eye snare.Upon pulling the lead back into the snare''s outer sheath, it was reported that the fillers of the lead balled up and broke through the side of the outer sheath.He ultimately got the snare to release, but the ball of fillers remained stuck in the sheath, attached to the lead remnant in the rv apex.Vascular surgery assisted for two hours and still the ball of fillers would not free from the coil to allow the femoral access point to be closed, so the decision was made to bring in a cardiothoracic surgeon.With this open heart procedure being staged and non emergent, the patient''s chest was opened to remove the lead and remnants through the heart.The patient survived the procedure.This report is being submitted due to the lld being present within the rv lead and provided traction, which may have caused or contributed to the lead breaking.There was no alleged malfunction of any spectranetics devices in use during the procedure.

Manufacturer Narrative

On 11 dec 2020, the philips representative visited at the account site and was able to obtain the following information regarding the spectranetics lead locking device (lld) involved in the event.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: STYLET, CATHETER
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 10973303
• MDR Text Key: 220434854
• Report Number: 1721279-2020-00246
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): Y
• PMA/PMN Number: K142116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/29/2022
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP20J25A
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COOK MEDICAL NEEDLE'S EYE SNARE; COOK MEDICAL NEEDLE'S EYE SNARE OUTER SHEATH; MEDTRONIC 6935 RV ICD LEAD; SPECTRANETICS TOOLS MENTIONED BUT NOT IDENTIFIED; COOK MEDICAL NEEDLE'S EYE SNARE; COOK MEDICAL NEEDLE'S EYE SNARE OUTER SHEATH; MEDTRONIC 6935 RV ICD LEAD; SPECTRANETICS TOOLS MENTIONED BUT NOT IDENTIFIED
• Patient Outcome(s): Required Intervention