EDWARDS LIFESCIENCES, PR SWAN-GANZ CCOMBO V CCO/SVO2/CEDV/VIP THERMODILUTION CATHETER; CATHETER, OXIMETER, FIBER-OPTIC
|
Back to Search Results |
|
Model Number 777F8 |
Device Problem
Material Split, Cut or Torn (4008)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/08/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
One 777f8 catheter with attached monoject 1.5 cc limited volume syringe was returned for examination.The customer's report of the the balloon not inflating was confirmed during evaluation.The balloon was found to be ruptured at central area of balloon latex and the ruptured edges were not able to match up.As received, blood was observed inside the balloon, gate valve, and returned syringe.All through lumens were patent without any leakage or occlusion.There was no visible damage or inconsistency observed from the catheter body and returned syringe.A review of the manufacturing records indicated that the product met specifications upon release.As part of the manufacturing process, 100% balloon inflation and visual inspection is performed.A product risk assessment was initiated to address the failure.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 part of this monthly review.
|
|
Event Description
|
It was reported that the balloon of the swan-ganz cco catheter did not inflate in the body during use.There was no patient injury or complications.During the product evaluation, the balloon was found to be ruptured at central area of balloon latex and the rupture edges were not able to match up.
|
|
Manufacturer Narrative
|
One 777f8 catheter with attached monoject 1.5 cc limited volume syringe was returned for examination.The customer's report of the the balloon not inflating was confirmed during evaluation.The balloon was found to be ruptured at central area of balloon latex and the ruptured edges were not able to match up.As received, blood was observed inside the balloon, gate valve, and returned syringe.All through lumens were patent without any leakage or occlusion.There was no visible damage or inconsistency observed from the catheter body and returned syringe.A review of the manufacturing records indicated that the product met specifications upon release.As part of the manufacturing process, 100% balloon inflation and visual inspection is performed.A product risk assessment was initiated to address the failure.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 part of this monthly review.
|
|
Event Description
|
It was reported that the balloon of the swan-ganz cco catheter did not inflate in the body during use.There was no patient injury or complications.During the product evaluation, the balloon was found to be ruptured at central area of balloon latex and the rupture edges were not able to match up.
|
|
Search Alerts/Recalls
|
|
|