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

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

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

Event Date 01/11/2023

Event Type  Injury  

Manufacturer Narrative

Patient's weight unk.Device model number, lot number, catalog number, expiration date and udi unk.510k number unk because model number unk.The device was discarded, thus no investigation could be completed.Device manufacture date unk because lot number unk.Lead damage is a known risk of complication with use of the glidelight device.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), a right ventricular (rv) and a left ventricular (lv) lead due to bacteremia.Spectranetics lead locking devices (llds) were inserted into each lead to provide traction.Using multiple spectranetics devices (14f glidelight laser sheath, 11f tightrail rotating dilator sheath), the ra lead was successfully removed.Working to remove the rv lead next, the physician used the 14f glidelight but progress stalled, so he upsized to a 16f glidelight, advancing to the lead's distal coil.The lead came free from the rv and when the lead was removed and observed outside the patient, there was tissue present on the lead's tip and the patient's blood pressure began to drop.Rescue efforts began immediately, including sternotomy.An rv perforation was discovered and repaired (mdr #1721279-2023-00018).To remove the lv lead, the physician alternated between the 14f glidelight and the 11f tightrail, with traction being applied from the lld, when the lv lead broke off at its tip.The lv vessel was too small to be able to snare the lead tip, so it remained in the patient with no further intervention.The patient survived the procedure.The patient was discharged and doing well.This report captures the lld present within the lv lead when the lead broke, requiring intervention but unsuccessful.There was no alleged malfunction of any spectranetics devices in use during the procedure.

• 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 ; 719447-246
• MDR Report Key: 16284663
• MDR Text Key: 308649542
• Report Number: 1721279-2023-00019
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 02/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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: ABBOTT 1501 RV ICD LEAD; SPECTRANETICS 11F TIGHTRAIL DILATOR SHEATH; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LEAD LOCKING DEVICES; ST. JUDE MEDICAL 1056/86 LV LEAD; ST. JUDE MEDICAL 1488TC/52 RA PACING LEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 89 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White