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

Model Number UNAVAILABLE

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

Patient Problems Iatrogenic Source (2498); Atrial Perforation (2511); Device Embedded In Tissue or Plaque (3165)

Event Date 10/06/2020

Event Type  Injury  

Manufacturer Narrative

Patient's weight unavailable.Device model number, lot number, expiration date and udi unavailable.Device 510k number unavailable because model number unavailable.Device manufacture date unavailable because lot number unavailable.

Event Description

A lead extraction procedure commenced to remove a right ventricular (rv) lead due to non function.A spectranetics lead locking devices (lld) was inserted in the lead to act as a traction platform to aid in extraction.The physician also chose to use a spectranetics glidelight laser sheath.The physician stated that he was going to use traction to remove the remainder of the lead, with the glidelight device appearing on fluoroscopy to be in the area of the tricuspid valve.The lead appeared to be adhered well from the tricuspid valve to the rv tip.The glidelight device was put into standby mode (not lasing).The physician then used a rapid traction technique, which resulted in a drop in the patient''s blood pressure.Rescue efforts began immediately.A sternotomy revealed a hole in the ra, which was repaired.At that time the physician also attempted to remove the remainder of the rv lead surgically but stated it was too calcified to be removed.The rv lead with the lld inside the lead were cut, capped and remained in the patient.Due to the nature of the event, it is unclear how much of the lead or lld was abandoned.It was reported that the physician did not attempt to unlock the lld prior to cutting and capping the rv lead.The patient survived the procedure.

Manufacturer Narrative

H6): patient code 2511 (atrial perforation) added to accurately reflect the patient outcome for this event.Although the atrial perforation was described in section b5 of the initial mdr, this patient code reflecting the atrial perforation was inadvertently omitted in h6.This omission was discovered 28 oct 2020.

• 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: 10748220
• MDR Text Key: 213453858
• Report Number: 1721279-2020-00216
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): Y
• 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: 10/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNAVAILABLE
• Device Catalogue Number: UNAVAILABLE
• Device Lot Number: UNAVAILABLE
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BOSTON SCIENTIFIC 0292 RV ICD LEAD; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS GLIDELIGHT LASER SHEATH; BOSTON SCIENTIFIC 0292 RV ICD LEAD; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS GLIDELIGHT LASER SHEATH
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 29 YR