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

Model Number 518-062

Device Problem Difficult to Advance (2920)

Patient Problems Low Blood Pressure/ Hypotension (1914); Tissue Damage (2104); Pericardial Effusion (3271)

Event Date 02/17/2015

Event Type  Injury  

Event Description

Lead management case to extract three cardiac leads due to cied system/pocket infection.All three leads were prepped with lld ezs.Extraction began on the rv (1646t-52) lead using a 12f sls.The lead was extracted successfully.The 12f sls was then used on the rv (px53-bp) lead but was unable to advance through the svc.The physician then switched to the ra (px45-jbp) lead; however the physician was still unable to make any progress, so the device was upsized to a 14f sls.Progress was still not possible, so the lead was switched to the rv lead.Again progress could not be made, so the physician returned to the ra lead.The ra lead was successfully extracted.A few minutes later while the physician was extracting the rv lead the blood pressure dropped and a small effusion was noted on tee.Pericardiocentesis was performed.The blood pressure increased, the rv lead was successfully extracted and the patient survived the intervention.The injury was noted to be in the ra; injuries of this type and size occur when the lead anchor releases from the cardiac wall.This report is being made on the lld ez as it was used as the traction platform to remove that lead.

Manufacturer Narrative

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• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD EZ
• Manufacturer (Section D): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS CORPORATION
• Manufacturer Contact: sondra chandler ; 9965 federal drive; colorado springs, CO 80921 ; 719447-253
• MDR Report Key: 4596131
• MDR Text Key: 22059665
• Report Number: 1721279-2015-00040
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K043401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2015
• 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
• Other Device ID Number: PARTIAL: M20451806205
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/17/2015
• 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: BIOTRONIC PX53-BP LEAD (IMPL. 171MO); SPECTRANETICS LEAD LOCKING DEVICE EZX2; SJM 1646T-52 LEAD (IMPL. 119MO); BIOTRONIC PX45-JBP LEAD (IMPL. 171MO); 14F SPECTRANETICS LASER SHEATH; 12F SPECTRANETICS LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 79 YR