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

Model Number 518-062

Device Problem Failure to Advance (2524)

Patient Problems Perforation (2001); Pericardial Effusion (3271)

Event Date 04/13/2015

Event Type  Injury  

Event Description

Lead management case to extract four leads due to cied system/pocket infection, thrombosis, rv-rv chatter and a non-functional lead.The rv lead (4034 impl.168 mo) was prepped with an lld ez and a 14f glidelight laser sheath with a 23cm visisheath were chosen due the amount of lead bulk in the clavicle.Significant lead to lead binding prevented advancement of the glidelight and visisheath.An 11f tightrail mini was then chosen and advanced proximal to the innominate/svc area.The physician then switched back to the 14f glidelight advancing to the rv where the passive lead was adhered.At that time traction alone was held on the lead with the lld ez for 3 minutes before the lead released from the myocardium.No drop in blood pressure was noted; however a pericardial effusion was noted.The physician performed a sternotomy and revealed a barely visible perforation in the posterior rv.The injury was sutured closed and the patient survived the intervention.

Manufacturer Narrative

(b)(4).

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD
• Manufacturer (Section D): SPECTRANETICS CORPORATION; 9965 federal dr.; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS CORPORATION
• Manufacturer Contact: sondra chandler ; 9965 federal dr.; colorado springs, CO 80921 ; 719447-253
• MDR Report Key: 4743844
• MDR Text Key: 5703767
• Report Number: 1721279-2015-00069
• 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: 04/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 09/23/2016
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP14J23A
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2014
• 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: GDT 4034 CARDIAC LEAD (IMPL. 168 MO); GDT 4243 CARDIAC LEAD (IMPL. 80MO); SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; GDT 0157 CARDIAC LEAD (IMPL. 72MO); SPECTRANETICS 12F GLIDELIGHT LASER SHEATH; GDT 4554 CARDIAC LEAD (IMPL. 72MO); SPECTRANETICS TIGHTRAIL MINI MECH. DILATOR SHEATH
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 82 YR
• Patient Weight: 35