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

Model Number 518-062

Device Problem Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Lead management case to extract two non-functional cardiac leads.The physician prepped the 4024 with an lld #2 and attempted removal using a 12f glidelight but after progress stalled an 11f tightrail was attempted.Unable to make progress the physician attempted to extract the 4524 lead by prepping with another lld and interchanging the glidelight and tightrail sheaths.Slight progress was made on this lead allowing the physician to insert two wires for lead re-implantation.At this time the physician decided not to continue the extraction leaving the llds cut and capped inside of the lead.No adverse effect has been experienced by the patient.The other lld will be reported under mdr # 1721279-2015-00191.

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 CORPORATION; 9965 federal dr.; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 5311154
• MDR Text Key: 34743593
• Report Number: 1721279-2015-00190
• 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: Initial,Followup,Followup
• Report Date: 12/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 09/17/2015
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: FLP15J17A
• 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: 09/17/2015
• 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: 44 YR
• Patient Weight: 162