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

Model Number 518-062

Device Problems Break (1069); Retraction Problem (1536)

Patient Problems Low Blood Pressure/ Hypotension (1914); Device Embedded In Tissue or Plaque (3165); Pericardial Effusion (3271)

Event Date 04/16/2014

Event Type  Injury  

Event Description

Lead management case to extract 2 cardiac leads due to high rv threshold.Both the ra (5076) and rv (6943) leads were extracted with no noticeable difficulty using llds and a 16f glidelight.After completing the extraction the patients bp dropped to 70/40; tee showed that there was a pericardial effusion most likely coming from the rv.The physician used a pericardiocentesis kit and removed approximately 400cc's of blood.The patient stabilized and was sent to ccu with no further episodes.The helix of the rv lead was not able to be retracted during the procedure and it was discovered that the helix was damaged from retraction attempts.The physician believed that the injury was a micro perforation caused by the inability of the lead helix to retract successfully.The lld is being reported in this case due to the physician using it as the traction platform and thereby potentially contributing to the injury caused by the 6943 cardiac lead.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD EZ
• Manufacturer (Section D): SPECTRANETICS CORPORTATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS CORPORTATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: sondra chandler rn ; 9965 federal drive; colorado springs, CO 80921 ; 7194472530
• MDR Report Key: 3799985
• MDR Text Key: 4382487
• Report Number: 1721279-2014-00063
• 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: 04/16/2014

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: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/16/2014
• Initial Date FDA Received: 05/08/2014
• 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: MDT 6943 SPRINT CARDIAC LEAD (IMPL. (B)(6) 2007); SPECTRANETICS LEAD LOCKING DEVICE EZ; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; MDT 5076 CAPSUREFIX NOVUS (IMPL. (B)(6) 2007); SPECTRANETICS 16F GLIDELIGHT LASER SHEATH
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 57 YR
• Patient Weight: 55