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

Model Number 518-067

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

Patient Problem Unspecified Infection (1930)

Event Date 11/10/2017

Event Type  Injury  

Manufacturer Narrative

Patient date of birth unavailable.Patient weight unavailable.Device lot number and expiration date unavailable.Device manufacture date unavailable.

Event Description

Lead extraction procedure to remove rv and lv leads, due to infection.The lv lead was extracted with only traction.The rv lead was prepped with lld ez, and then the procedure began using 14f gl.After lasing at subclavian about 5 sec, the lead tip freed and the lead was extracted by traction.At this point, the blood pressure had no change; however, the physician confirmed small effusion by tee.After 15 minutes follow-up, it did not get worse.The surgeon performed incision and a drain tube was placed.According to the physician, the injury part could have been cardiac apex.

• Brand Name: SPECTRANETICS LLD EZ LEAD LOCKING DEVICE
• Type of Device: LLD
• Manufacturer (Section D): SPECTRANETICS; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 7077272
• MDR Text Key: 93565090
• Report Number: 1721279-2017-00281
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K142116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 518-067
• Device Catalogue Number: 518-067
• Device Lot Number: UNAVAILABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2017
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 68