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

Model Number 518-062

Device Problem Retraction Problem (1536)

Patient Problems Bacterial Infection (1735); Low Blood Pressure/ Hypotension (1914); Atrial Perforation (2511)

Event Date 11/18/2014

Event Type  Injury  

Event Description

Lead management case to extract four leads due to cied system/pocket infection and bacteremia.The 4076 ra lead was prepped with an lld and a 14f glidelight was used.The lead popped free of the atrial wall without the screw being retracted.The patient's blood pressure dropped significantly, so the ct surgeon performed a sternotomy.During the sternotomy, it was discovered that the patient had an atrial tear along with several small tears in the innominate area of the subclavian.An atrialectomy was performed due to vegetation that was identified on the tricuspid; the injuries were repaired and the extraction of the remaining leads was conducted.The patient survived the intervention.This report on the lld is to reflect the atrial injury since it was likely caused by the traction applied to the lead.The lld in this case was used as the traction platform.The innominate injuries will be reported under mdr # 1721279-2014-00208.

Manufacturer Narrative

(b)(4).

• 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: 4291855
• MDR Text Key: 18293076
• Report Number: 1721279-2014-00209
• 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: 11/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2014
• 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: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2014
• 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: SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS GLIDELIGHT LASER SHEATH; MDT 4076 CARDIAC LEAD (IMPL. 156 MO); UNK MAN. ICF09 B58 CARDIAC LEAD (IMPL. 132 MO); BSC 4035 CARDIAC LEAD (IMPL. 156 MO); BSC 4017 CARDIAC LEAD (IMPL. 156 MO)
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention