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

Model Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Pericardial Effusion (3271)

Event Date 11/10/2014

Event Type  Injury  

Event Description

Lead management case to extract two leads due to cied system/pocket infection.The rv (4092) lead was extracted successfully without incident and then the ra lead (5568) was removed.Approximately 5 minutes after removal of the ra lead a drop in blood pressure was noted.An echo was performed revealing an effusion.The ct surgeon performed a pericardial window and placed a drain resulting in the patient's blood pressure recovering.The physician believed that an injury was caused in the ra when the lead became free from the wall.This report is being made on the lld since it was used as the traction platform to remove the lead when the injury occurred.Patient survived the intervention.

Manufacturer Narrative

Udi number unknown: the model number of the device could not be determined as it was not recorded in the patient's record what model of lld was used in the ra when the injury occurred.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD
• 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: 4291849
• MDR Text Key: 5081097
• Report Number: 1721279-2014-00205
• 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: 11/11/2014

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: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/11/2014
• Initial Date FDA Received: 12/02/2014
• 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 4092 CARDIAC LEAD (IMPL. 120 MO); SPECTRANETICS LEAD LOCKING DEVICE (UNK MODEL); SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS GLIDELIGHT LASER SHEATH; MDT 5568 CARDIAC LEAD (IMPL. 120 MO); SPECTRANETICS VISISHEATH DILATOR SHEATH
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention