MAUDE Adverse Event Report: SPECTRANETICS CORPORATION SPECTRANETICS LEAD LOCKING DEVICE; LLD #2

Model Number 518-019

Device Problem Human-Device Interface Problem (2949)

Patient Problems Low Blood Pressure/ Hypotension (1914); Laceration(s) (1946)

Event Date 06/03/2014

Event Type  Injury  

Event Description

This was a cardiac lead extraction case to remove two leads due to a cied pocket infection.Each of the leads were prepped with an lld #2 and a 12f glidelight was used to successfully extract the rv pacing lead first.The sheath progressed smoothly, however, there was scarring on the leads.After extracting the rv lead, the physician began to lase on the ra pacing lead.Significant scarring was noted on this lead, but the laser progressed smoothly until the sheath was close to the tip of the ra lead.Steady traction was held on the lld and lead for a few minutes then the lead freed up.The lead and laser sheath were pulled out gently and the patient's blood pressure dropped.A pericardiocentesis, then a sternotomy was performed.A small tear at the tip of the atrial appendage was discovered and sutured.New leads and a new pacemaker were installed, and the patient recovered from the intervention.The injury is being attributed to the lld in this case because it was being used as the traction platform to pull the lead free from the myocardium.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD #2
• Manufacturer (Section D): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: jessica hearn bsn, rn ; 9965 federal drive; colorado springs, CO 80921 ; 7194472258
• MDR Report Key: 3887224
• MDR Text Key: 4649958
• Report Number: 1721279-2014-00092
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 518-019
• Device Catalogue Number: 518-019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/03/2014
• Initial Date FDA Received: 06/20/2014
• 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: BIOTRONIK SELOX JT RA PACING (IMPL 57 MONTHS); SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; BIOTRONIK SELOX ST RV PACING (IMPL 57 MONTHS); SPECTRANETICS 12F GLIDELIGHT LASER SHEATH; SPECTRANETICS LEAD LOCKING DEVICE (LLD#2)
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 89 YR
• Patient Weight: 44