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

Model Number 518-062

Device Problems Difficult to Advance (2920); Material Protrusion/Extrusion (2979)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/16/2017

Event Type  malfunction  

Manufacturer Narrative

Patient age, date of birth, gender and weight are unavailable.The device and lead were returned to the manufacturer for evaluation.The device was still locked within the lead upon receipt to the manufacturer.Visual inspection of the device found evidence of the lead being compromised.It is probable that the age of the lead contributed to the degradation in integrity.No evidence was observed to indicate that the lld device malfunctioned to cause this event.

Event Description

It was reported that during a lead extraction procedure, the lld device protruded from the end of the lead.Reportedly, it was initially difficult to advance the lld to the tip of the lead.A stiff stylet was used to advance further into the lead, and clearing stylet was used to advance fully to the tip.The lld was then re-inserted to a more distal portion of the lead than before.Fluoroscopy was then used to confirm placement.The physician reportedly felt that the deployment mechanism had locked and that there was an abnormal amount of slack in the lld.On fluoroscopy, it was identified that the fluoro marker and interior mandrel of the device were deployed past the tip of the lead.The locking mechanism was stable despite this fact, and the lead was successfully extracted with the aid of a visisheath device.The patient was not affected.

Manufacturer Narrative

Patient age, weight, and gender have been provided.Patient pre-op labs have been provided.Patient pre-existing medical conditions have been provided.

• 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: nick mcnabb ; 9965 federal drive; colorado springs, CO 80921 ; 719447-257
• MDR Report Key: 6851824
• MDR Text Key: 86007919
• Report Number: 1721279-2017-00196
• 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: 08/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/21/2019
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP17D11A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2017
• 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): Other
• Patient Age: 40 YR
• Patient Weight: 104