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

Model Number 518-062

Device Problem Insufficient Information (3190)

Patient Problem Perforation (2001)

Event Date 05/02/2017

Event Type  Injury  

Manufacturer Narrative

Patient weight is unavailable.Facility personnel declined to provide this information.Device lot number and expiration date are unavailable.The device was discarded before this information could be obtained.Device manufacture date is dependent on the device lot number, thus is unavailable.

Event Description

It was reported that during a lead extraction procedure to remove 2 non-functional leads (ra and rv) a perforation to the right ventricle (rv) occurred.Reportedly, the rv lead was prepped with a lead locking device (lld) and a glidelight laser sheath was used to progress down the lead until the superior vena cava (svc), and no further.Traction force was then applied to the lead using the lld and the lead released from the cardiac wall.The release of the lead resulted in a perforation to the rv wall.A pericardiocentesis was performed and the injury closed (clotted) on its own.

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
• Manufacturer (Section D): SPECTRANETICS; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS
• Manufacturer Contact: jason hearn ; 9965 federal dr.; colorado springs, CO 80921 ; 719447-236
• MDR Report Key: 6585299
• MDR Text Key: 75769298
• Report Number: 1721279-2017-00099
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2017
• 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: UNAVAILABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2017
• 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
• Treatment: MEDTRONIC ICD LEAD 6945 (IMPL 17MO); MEDTRONIC PACING LEAD 6940; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS GLIDELIGHT LASER SHEATH; SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 69 YR