Catalog Number ZIV5-125-7-4.0 |
Device Problem
Material Deformation (2976)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 12/08/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
Pma/510(k) #: p050017/s002 and s003.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
|
|
Event Description
|
The stent is kinked and cannot fit the wire guide in the stent.Stent has been changed patient outcome: a section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Patient/event info - notes: the event of complaint dates back more than a month and i don¿t have more details than the complaint report from pharmacist.More if we look the cause of this complaint ( the stent is kinked and cannot fit the wire guide in the stent ) many of you questions list are not relevant expect q5 : yes devices kinked.
|
|
Manufacturer Narrative
|
Pma/510(k) #: p050017/s002 and s003.Cancellation report being submitted, complaint was reassessed as not reportable following device evaluation.Outer sheath was found to be kinked not the stent.Lab evaluation completed on 26jan2021, the following was noted: kink observed approx 54.8cm from white connection cap on outer sheath.Slight kink observed approx 5.0cm from the distal white tip along the outer sheath.Device flushed as expected.0.018" wire guide could not pass the kinks on the outer sheath.
|
|
Event Description
|
Cancellation report being submitted, complaint was reassessed as not reportable following device evaluation being completed on 26-jan-2021.Outer sheath was found to be kinked not the stent.The stent is kinked and cannot fit the wire guide in the stent.Stent has been changed.Patient outcome: a section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Patient/event info - notes: the event of complaint dates back more than a month and i don¿t have more details than the complaint report from pharmacist.More if we look the cause of this complaint ( the stent is kinked and cannot fit the wire guide in the stent ) many of you questions list are not relevant expect q5 : yes devices kinked.
|
|
Search Alerts/Recalls
|