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.They then used a third lld-ez to prepare the lead again, it went well inside the lead until the apex, but upon applying traction at this point, the third lld-ez slipped back to svc and then to the subclavian region.This report is being submitted to capture the malfunction of the third lld.(please see 1721279-2019-00151 and 1721279-2019-00152 for the other llds in use.) 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 completion of device evaluation.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.
|
|
Search Alerts/Recalls
|
|