EDWARDS LIFESCIENCES SWAN-GANZ BIPOLAR PACING CATHETER FOR SVC INSERTION; ELECTRODE, PACEMAKER, TEMPORARY
|
Back to Search Results |
|
Model Number PE074F5 |
Device Problem
Pacing Problem (1439)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 01/13/2024 |
Event Type
malfunction
|
Manufacturer Narrative
|
The device is anticipated to be returned for evaluation but has not yet been received.A supplemental report will be forthcoming when the investigation is completed, as well as the device history record review results.
|
|
Event Description
|
It was reported that during use, it was unable to pace.Pacing was attempted after catheter insertion, but it did not work.The issue was resolved by replacing the catheter.Information including the kind of surgery or examination the catheter was used for and if the patient had cardiac conduction defect was unknown.The patient demographic information was requested but unavailable.There were no patient complications reported.
|
|
Manufacturer Narrative
|
Our product evaluation lab received one bipolar pacing catheter with attached monoject 1.3 cc limited volume syringe.The reported pacing issue was confirmed.Continuity testing found that a short condition occurred between the proximal and distal circuits in the y-adaptor.There were no open or short conditions observed in the leadwires between the distal side of y-adaptor and the electrodes.The balloon inflated clear and concentric and remained inflated for five minutes without leakage.It was able to open and lock the gate valve without any resistance, but the seal inside the gate valve was found to be deformed.There was no other visible damage observed from catheter body, balloon, returned syringe and windings.An engineering evaluation was performed to assess for any manufacturing related processes which could be correlated to the complaint.The complaint failure is associated to a manufacturing/design defect.As part of the manufacturing process 100% of the units go through an electrical continuity inspection process.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 part of this monthly review.Correction: the correct lot number of 65114736 was provided.
|
|
Search Alerts/Recalls
|
|
|