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

Model Number 518-019

Device Problems Break (1069); Material Frayed (1262)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/15/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Only partial device will be retruned to spectranetics as part of the device remains in the patient.A follow up report will be provided post device investigation.

Event Description

Lead management case to extract leads due to lead malfunction.The physician prepped the bsc 4088 lead with an lld #2 locking stylet and attempted lead extraction.The physician used a kelly hemostatic set of forceps to grab the lead and lld combination to provide traction.After performing a few lasing trains with a glidelight laser sheath it was noted that there was some fraying on the lld where the forceps had been placed.Progress was made on the lead; however the lead structure began to degrade.Several attempts were made at securing the insulation to maintain lead integrity but the entire lead and lld #2 eventually broke.The physician decided to stop the removal attempt, leaving a portion of the lld cut/capped inside of the lead.New leads were placed in the patient and the patient was discharged.

Manufacturer Narrative

Device evaluation: all components of the lld were returned and present during the device evaluation; no part of the lld remains in the patient as originally reported.The device braid broke at the location of the capture assembly and the mandrel pulled out of the tip.Mandrel kinks/damage distal of the mandrel wave indicate where the kellys were used on the lld and potentially causing the braid to break at this location.

• 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: sondra chandler ; 9965 federal dr; colorado springs, CO 80921 ; 719447-253
• MDR Report Key: 5167325
• MDR Text Key: 29224002
• Report Number: 1721279-2015-00162
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043401
• 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: 10/15/2015

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: 07/22/2017
• Device Model Number: 518-019
• Device Catalogue Number: 518-019
• Device Lot Number: FLC15G22A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/15/2015
• Initial Date FDA Received: 10/21/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/06/2015; 03/20/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/22/2015
• 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: 52 YR
• Patient Weight: 51