MAUDE Adverse Event Report: SPECTRANETICS CORPORTATION SPECTRANETICS GLIDELIGHT LASER SHEATH; 14F GLIDELIGHT

Model Number 500-302

Device Problem Physical Resistance (2578)

Patient Problems Injury (2348); Blood Loss (2597)

Event Date 07/16/2014

Event Type  Injury  

Event Description

Lead management case to extract three leads due to cied system/pocket infection.The 1056 lv lead was extracted easily without the use of extraction tools.An lld was placed in the 1571 rv lead.The physician began lasing with a 14f glidelight and intermittently used the outer sheath for mechanical dissection.Upon reaching the distal end of the distal coil near the ivc difficulty was encountered.The physician decided to upsize the device to a 16f glidelight but after removing the 14f glidelight a significant loss of blood through the pocket was noticed.A sternotomy was performed revealing two injuries; one in the svc/ra junction and the other in the ivc.The surgeon repaired both injuries and the patient survived the intervention.All extraction tools were removed and the remainder of the leads were abandoned.

• Brand Name: SPECTRANETICS GLIDELIGHT LASER SHEATH
• Type of Device: 14F GLIDELIGHT
• 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: 3967740
• MDR Text Key: 4626717
• Report Number: 1721279-2014-00118
• Device Sequence Number: 1
• Product Code: MFA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960042
• 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: 07/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 500-302
• Device Catalogue Number: 500-302
• Device Lot Number: UNKNOWN
• Other Device ID Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/16/2014
• 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 LEAD LOCKING DEVICE; SJM 1571 RIATA LEAD (IMPL. 41 MO); SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SJM 1056 QUICKSITE LEAD (IMPL. 41 MO) X2
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 85