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

Model Number 518-019

Device Problem Mechanical Jam (2983)

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

Event Date 03/23/2021

Event Type  malfunction  

Manufacturer Narrative

Device evaluation: the device was returned to the manufacturer and evaluated on 31 march 2021 by a cross functional team.The lld was returned, still stuck within the tightrail.The distal most tip of the lld had the lead coiled around it.Pulling from the proximal end the lld, lead and cook bulldog were removed from the tightrail.It was observed the distal epoxy plug on the lld was not present, however, the rest of the lld was intact.It was unable to be determined when or how the epoxy plug at the distal tip of the lld became detached.Philips physician and associate director of medical affairs reviewed the event and size of the epoxy tip.It was estimated by the engineers to be 1mm x 0.4mm, and was determined to not be clinically significant or noticeable if indeed it had embolized into a small pulmonary arteriole (assuming it did not remain in the distal part of the rv lead portion that was abandoned in the rv).The component code and health effect impact code (heic) field was intentionally left blank.

Event Description

A lead extraction procedure commenced to remove a right ventricular (rv) lead due to malfunction.A spectranetics lead locking device (lld) was inserted into the rv lead to provide traction to the lead to aid in extraction.The physician began by using a spectranetics 14f glidelight laser sheath and a medium visisheath dilator sheath.Advancement was made in the vasculature until they reached the end of the superior vena cava (svc) coil, where progress stalled.The physician chose to switch to a spectranetics tightrail rotating dilator sheath but progress stalled in the same area.However, also at that time, the tightrail device became stuck in the patent's body, unable to progress forward or remove the device (please reference mdr 1721279-2021-00065 which captures the tightrail device which became stuck in the patient's body).The physician chose to snare the lead from a femoral approach, and then the lead broke, leaving a portion of the rv lead from the lead's distal coil to the distal tip, where it attached into the rv, approximately 3 inches.This allowed the tightrail to be removed from the patient's body.The physician attempted to snare the remnant of the rv lead from a femoral approach using a gooseneck snare for over an hour but could not grasp the end of the rv lead.It was thought that the lead's distal coil was so embedded into the rv that snaring could not take place, so the rv remnant was abandoned within the patient.The patient survived the procedure with no reported patient harm and at that time, there was no plan to attempt removal of the rv portion at a later date.The tightrail device, with the lld, portion of rv lead and cook medical bulldog lead extender inside the tightrail was returned on 30 mar 2021.Device evaluation is written although a gooseneck snare was in use at the time the lead broke, this report is being submitted to capture the lld, present in the rv lead, which may have contributed to the lead breaking and has the potential for injury with recurrence.

Manufacturer Narrative

H6): added codes: 772 and 2199.

• 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: 11693058
• MDR Text Key: 246269733
• Report Number: 1721279-2021-00064
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023010
• UDI-Public: (01)00813132023010(17)230112(10)FLC21A08A
• Combination Product (y/n): Y
• PMA/PMN Number: K990713
• Number of Events Reported: 123
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/12/2023
• Device Model Number: 518-019
• Device Catalogue Number: 518-019
• Device Lot Number: FLC21A08A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BOSTON SCIENTIFIC 0184 RV ICD LEAD.; COOK BULLDOG LEAD EXTENDER.; GOOSENECK SNARE MANUFACTURER UNKNOWN.; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH.; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM.; SPECTRANETICS MEDIUM VISISHEATH DILATOR SHEATH.; SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH.; BOSTON SCIENTIFIC 0184 RV ICD LEAD; COOK BULLDOG LEAD EXTENDER; GOOSENECK SNARE MANUFACTURER UNKNOWN; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS MEDIUM VISISHEATH DILATOR SHEATH; SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH
• Patient Outcome(s): Other
• Patient Age: 41 YR