Model Number PE075F5 |
Device Problem
Material Split, Cut or Torn (4008)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
malfunction
|
Manufacturer Narrative
|
The reported event of the balloon did not inflate was confirmed.Balloon did not inflate due to leakage from a tear at distal side of balloon latex.After cutting the proximal side of balloon, it was confirmed the balloon latex edges were not able to match up.No visible damage was found from catheter body, returned syringe and balloon windings.Further evaluation regarding related quality issues is under investigation.A device history record review was completed and documented that device met all specifications upon distribution.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis and any excursions above the control limits are assessed and documented as a part of the monthly review.
|
|
Event Description
|
It was reported that the balloon of a swan ganz catheter did not inflate during use.The brand and size of the introducer and date of event is unknown.There were no patient complications reported.Per pe findings, balloon was found torn with latex edges not able to match up.
|
|
Manufacturer Narrative
|
Engineering evaluation was completed and concluded a product risk assessment was met earlier.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis and any excursions above the control limits are assessed and documented as a part of the monthly review.
|
|
Search Alerts/Recalls
|