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

Model Number 518-019

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 04/22/2022

Event Type  Injury  

Manufacturer Narrative

Device lot number, expiration date unk.The device was discarded, thus no investigation could be completed.Device manufacture date unk because lot number unk.

Event Description

A lead extraction procedure commenced to remove a right atrial (ra) and a right ventricular (rv) lead due to cied system/pocket infection.Spectranetics lead locking devices were inserted into each lead (near or at distal tip of each lead) to provide traction.A spectranetics 13f tightrail rotating dilator sheath was used to attempt removal of the rv lead, and a spectranetics 14f glidelight laser sheath along with a spectranetics visisheath dilator sheath was used for the ra lead.During the procedure, both leads stretched while significant traction was being applied with use of the llds, and they broke near the clavicle area (mdr #1721279-2022-00088 for rv).Due to the stretching of the leads, the llds had nothing to lock onto within the leads, and they slipped out of each lead, along with the proximal lead portions.There were 3 physicians in the room, so they planned to snare each lead from different femoral access points: the ra lead was successfully snared from a right femoral access using a cook medical needle's eye snare with no complications, and a snaring attempt to remove the rv lead was performed from a left femoral access using an argon medical atrieve vascular snare.The left femoral sheath wasn't large enough, so the ct surgeon peeled the sheath and reached in with a clamp to pull out the atrieve snare and rv lead remnant.The left femoral vein was damaged by this and bleeding was uncontrolled, so the ct surgeon surgically cut down the vein and repaired the left leg.The procedure was completed and the patient survived the procedure.This report captures the lld providing traction within the ra lead when the lead broke, requiring intervention to remove the lead remnant.There was no alleged malfunction of any spectranetics devices in use during the procedure.The injury to the left femoral vein occurred when the physician used the clamp to pull out the atrieve snare and rv lead remnant, and was unrelated to any spectranetics devices.

• 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: 14349262
• MDR Text Key: 291387468
• Report Number: 1721279-2022-00089
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023010
• UDI-Public: 00813132023010
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K990713
• 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: 04/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 518-019
• Device Catalogue Number: 518-019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/22/2022
• 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: ARGON MEDICAL ATRIEVE VASCULAR SNARE; BOSTON SCIENTIFIC 0158 RV ICD LEAD; BOSTON SCIENTIFIC 4470 RA PACING LEAD; CLAMP MANUFACTURER AND TYPE UNK; COOK MEDICAL NEEDLE'S EYE SNARE; SPECTRANETICS 13F TIGHTRAIL DILATOR SHEATH; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LEAD LOCKING DEVICE IN RV LEAD; SPECTRANETICS VISISHEATH DILATOR SHEATH
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 80 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White