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

Model Number 518-019

Device Problem Difficult to Remove (1528)

Patient Problems Iatrogenic Source (2498); Device Embedded In Tissue or Plaque (3165)

Event Date 12/13/2018

Event Type  malfunction  

Manufacturer Narrative

The device remains cut/capped within the implanted cardiac lead which is within the patient.Therefore evaluation is not possible.

Event Description

A philips representative reported that a cardiac lead management procedure to extra two non-functional/occluded leads commenced.One lead was in the right atrium (ra) and one in the right ventricle (rv).A spectranetics lead locking device (lld) 518-019 was utilized when attempting to extract the right ventricular (rv) lead.The physicians decided to abandon extraction, due to lack of progress and inability to progress past a difficult scarred area in the superior vena cava(svc)/right atrial (ra) junction.The physician was unable to unlock and remove the lld.Therefore, the lead and lld were cut and left within the patient's anatomy.Neither lead was extracted.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: catherine eaton ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 8213104
• MDR Text Key: 132294818
• Report Number: 1721279-2019-00002
• Device Sequence Number: 1
• Product Code: DRB
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K990713
• 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
• Report Date: 01/01/2005,12/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/20/2019
• Device Model Number: 518-019
• Device Catalogue Number: 518-019
• Device Lot Number: FLC17M14A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 12/13/2018
• Initial Date FDA Received: 01/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2017
• 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: 37 YR
• Patient Weight: 86