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

Model Number 518-062

Device Problems Break (1069); Failure to Advance (2524)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/11/2017

Event Type  Injury  

Manufacturer Narrative

Patient's date of birth unavailable.

Event Description

Dr.Attempted an extraction of a fractured rv lead.Dr.Began the procedure utilizing a 14f glide light laser sheath, a teflon outer sheath, and an ez lld.Severe binding was experienced almost immediately, as he advanced the laser sheath towards the svc/innominate junction, as the laser sheath approached the svc coil.After 4 trains on the laser, the decision was made to upsize to a 16f glide light laser sheath and a teflon outer sheath.Once again, severe binding was encountered and physician was unable to advance the laser sheath.Further, the lead began to break which was visibly evident under fluoroscopy.The decision was made to gain access, place an adjacent lead, and abandon the extraction.An ez lld remains inside the capped rv lead.Procedure was otherwise successful.Patient made a full recovery.

• 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: 6917671
• MDR Text Key: 88385341
• Report Number: 1721279-2017-00218
• 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
• Report Date: 09/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 06/02/2019
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FGB17E31A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2017
• 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): Required Intervention
• Patient Age: 56 YR
• Patient Weight: 103