MAUDE Adverse Event Report: SPECTRANETICS SPECTRANETICS LEAD LOCKING DEVICE; LLD

Model Number 518-039

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Cardiac Tamponade (2226); Injury (2348); Pericardial Effusion (3271)

Event Date 06/28/2017

Event Type  Injury  

Event Description

Procedure for extraction of 3 leads.Stalled progress occurred on the rv lead (using a 14f glidelight laser sheath) at the proximal coil.A 11f tight rail was then used to free the lead-on-lead binding.After getting ¾ of the way down the distal coil the lead dislodged.After removing the tight rail a large piece of myocardial tissue was adhered to the lead tip.Shortly after the pressure dropped and an effusion was noted and a cardiac tamponade ensued.Rescue efforts commenced immediately; sternotomy was performed and an injury to the rv anterior wall was discovered/repaired.Patient survived the procedure.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD
• Manufacturer (Section D): SPECTRANETICS; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 6731793
• MDR Text Key: 80671160
• Report Number: 1721279-2017-00141
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 518-039
• Device Catalogue Number: 518-039
• Device Lot Number: UNAVAILABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2017
• 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: SPECTRANETICS 11F TIGHTRAIL DILATOR SHEATH; SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 92