Catalog Number RA-04122 |
Device Problem
Material Twisted/Bent (2981)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/12/2024 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).
|
|
Event Description
|
It was reported that: "there was no scar tissue.The wire treaded easily, however when the catheter was advanced, resistance was met.I tried to retract the wire but was unable to do this.I then stopped advancing and pulled out the entire line, catheter , and wire.There was more resistance on retraction than expected as well.That is when we noticed the wire kinked and the damaged catheter.No fragments were left in the patient.A new catheter was placed." a photo shows that the guidewire is kinked, and the arterial catheter tip was damaged.Associated complaints 9680794-2024-00215 and 9680794-2024-00216.
|
|
Event Description
|
It was reported that: "there was no scar tissue.The wire treaded easily, however when the catheter was advanced, resistance was met.I tried to retract the wire but was unable to do this.I then stopped advancing and pulled out the entire line, catheter , and wire.There was more resistance on retraction than expected as well.That is when we noticed the wire kinked and the damaged catheter.No fragments were left in the patient.A new catheter was placed." a photo shows that the guidewire is kinked, and the arterial catheter tip was damaged.Associated complaints 9680794-2024-00215 and 9680794-2024-00216.
|
|
Manufacturer Narrative
|
(b)(4) complaint verification testing could not be performed as no sample was returned for analysis.The instructions-for-use (ifu) provided with this kit warns the user, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage.If damage is suspected or withdrawal cannot be easily accomplished, radiographic visualization should be obtained, and further consultation requested." a device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
|
|
Search Alerts/Recalls
|
|