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

Model Number 518-062

Device Problem Occlusion Within Device (1423)

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

Event Date 08/18/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

This was a left-sided lead implantation procedure.The physician was not able to drop a wire to implant the new lead due to occlusion, so he decided to use a 12f glidelight laser sheath and outer sheath on the ra lead ((b)(4) ra pacing, impl 58 months) to get past the occlusion with the intent to add a new lv lead.The physician prepped the ra lead with an lld ez and sutures and used the laser catheter with an outer sheath to get past the occlusion.Once he was past the occlusion he pulled the 12f laser catheter out while maintaining the position with the teflon outer sheath.He dropped a wire and then added an lv lead.The physician did not want to attempt to extract the entire ra lead because of the patient's status and because the lead was attached to the svc coil of another lead ((b)(4) rv icd lead, impl 58 months).Once the new lead was implanted, the physician elected to cut and cap the ra lead with the lld ez inside the lumen in lieu of putting the patient at risk of extracting the lead.The physician deemed the procedure to be a success.The patient was discharged per operative plan.

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: 5022929
• MDR Text Key: 24700181
• Report Number: 1721279-2015-00133
• 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: 08/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 06/24/2017
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP15F24A
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/21/2015
• Supplement Dates Manufacturer Received: Not provided; 08/17/2017
• Supplement Dates FDA Received: 03/20/2017; 08/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2015
• 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
• Patient Outcome(s): Other
• Patient Age: 79 YR
• Patient Weight: 51