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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS LEAD LOCKING DEVICE; LLD
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THE SPECTRANETICS CORPORATION SPECTRANETICS LEAD LOCKING DEVICE; LLD Back to Search Results
Model Number 518-062
Device Problems Mechanical Problem (1384); Activation, Positioning or Separation Problem (2906)
Patient Problem No Code Available (3191)
Event Date 08/07/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).The user facility did not return the device due to exposure to the patient's blood.
 
Event Description
A philips representative reported that a cardiac lead management procedure commenced.Two infected pacemaker leads were to be extracted, (1 right ventricular (rv), 1 right atrial(ra)), using the spectranetics lead locking device (lld) ez and the spectranetics 11fr tightrail rotating dilator sheath.Both infected leads were prepared with an lld-ez.When the physician was applying traction on the leads, the lld-ezs slipped back in both the leads to the superior vena cava (svc) and then further back to the subclavian region.This report is being submitted for the lld in the ra lead which slipped back.A third lld was also employed, and the same issue occurred.(please see mdr 1721279-2019-00151 and 1721279-2019-00153 for the other llds involved).The physician was unable to extract the infected leads with the llds.The procedure was abandoned and the patient was referred the cardio-thoracic vascular surgery team for open heart surgery to remove the infected leads.
 
Manufacturer Narrative
Correction to b4) date manufacturer became aware of event corrected to (b)(6) 2019.
 
Manufacturer Narrative
D10): device was returned for evaluation on (b)(6) 2019.H6): methods, results and conclusions codes now populated after device evaluation completed.Device evaluation: the device was returned and evaluated by a cross functional team on (b)(6) 2019.The team noted that the inner coils from the lead had been broken, and were present at the distal end of the lead locking device (lld) and extended distally from the distal tip of the lld.The inner coils of the lead located distally of the lld had been stretched and unraveled indicating the insulation of the lead had been compromised, either prior to or during an attempt to remove the lead.Due to the condition (broken, stretched, unraveled) of the inner coils that were present on the lld, it was confirmed that the lld was not placed as far distally as possible, to the tip of the lead.It is unknown why the lld was not placed at the distal tip of the lead.The lld performed as intended during the procedure.
 
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Brand Name
SPECTRANETICS LEAD LOCKING DEVICE
Type of Device
LLD
Manufacturer (Section D)
THE SPECTRANETICS CORPORATION
9965 federal drive
colorado springs CO 80921
MDR Report Key8965060
MDR Text Key156613003
Report Number1721279-2019-00152
Device Sequence Number1
Product Code DRB
Combination Product (y/n)Y
PMA/PMN Number
K142116
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup,Followup
Report Date 01/01/2005,08/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/05/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/14/2021
Device Model Number518-062
Device Catalogue Number518-062
Device Lot NumberFLK19B13A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/12/2019
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Date Report to Manufacturer01/10/2005
Date Manufacturer Received11/13/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
PACEMAKER LEAD (UNKNOWN MANUFACTURER/MODEL); SPECTRANETICS LEAD LOCKING DEVICE; SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH; PACEMAKER LEAD (UNKNOWN MANUFACTURER/MODEL); SPECTRANETICS LEAD LOCKING DEVICE; SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age58 YR
Patient Weight68
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