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

Model Number 518-062

Device Problem Human-Device Interface Problem (2949)

Patient Problem Cardiac Perforation (2513)

Event Date 08/11/2015

Event Type  Injury  

Manufacturer Narrative

Device 510k number has been corrected to reflect the most current and up to date number, as of the date of the initial report.

Event Description

This was a left-sided lead extraction to remove two non-functional rv leads (mdt 6949 capped rv lead and mdt 6944 active rv lead).Two other active leads were not planned for extraction in this case (mdt 5076 ra lead and mdt 4194 lv lead).Each of the leads was prepped with an lld-ez and 14f and 16f glidelight laser sheaths were used to extract.The mdt 6949 rv lead was extracted successfully.During extraction of the mdt 6944 passive rv lead, a perforation was noted on tee.Ct surgeon was called and initiated pericardiocentesis followed by sternotomy.The patient was stable throughout the procedure.An injury to the rv apex was found and repaired.The injury occurred as the lead pulled free from the myocardium.As the lld was the traction platform used to pull the lead free, it is the device that contributed to the injury.A new rv lead was implanted post-repair and the patient was doing well.

Manufacturer Narrative

Device 510k number has been corrected to reflect the most current and up to date number, as of the date of the initial report.

Manufacturer Narrative

Device 510k number has been corrected to reflect the most current and up to date number, as of the date of the initial report.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD-EZ
• Manufacturer (Section D): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 7194472258
• MDR Report Key: 5013568
• MDR Text Key: 23422493
• Report Number: 1721279-2015-00127
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Followup,Followup
• Report Date: 08/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 01/22/2017
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP15A22A
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2015
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 53 YR
• Patient Weight: 86