|
Model Number 518-039 |
Device Problem
Material Separation (1562)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/09/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
Patient's date of birth, age unk; patient's weight unk; relevant tests/laboratory data unk; other relevant history unk; device evaluated by mfr: the device was not returned to the manufacturer, thus the cause of the reported failure could not be confirmed.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.
|
|
Event Description
|
A lead extraction procedure commenced to remove a right ventricular (rv) lead.A spectranetics lead locking device (lld) was inserted into the lead to provide traction.The physician used a spectranetics 13f tightrail rotating dilator sheath and during the procedure, the lld separated outside the patient, in the intermediate-distal section (unknown if within the working length).The proximal and distal sections of the lld were re-attached together and the rv lead was successfully extracted with no reported patient harm.This event captures the lld that separated during use, potential for harm with recurrence.
|
|
Manufacturer Narrative
|
D9): the lld was returned to the manufacturer on 04apr2023.G3/h2): the device evaluation and investigation were completed 20apr2023.H3): the lld device was returned in two portions, separated at the waveform, 3.5 inches from the distal loop hypotube.The proximal portion had been flipped around and tied to the distal portion.The lld was stretched, with the diameter becoming smaller up to the area of the separation.The lld was deformed, with markings present on the proximal part of the mandrel, resembling clamp markings.H6): the cause of the reported failure could not be established based on the information provided by the distributor.No clamps were placed on the device, and the lld was used in accordance with ifu technique.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.
|
|
Search Alerts/Recalls
|
|
|