Model Number PE074F5 |
Device Problem
Pacing Problem (1439)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
malfunction
|
Event Description
|
It was reported that a swan ganz catheter was unable to pace from the beginning of use after the catheter insertion for rapid pacing of tavi procedure.The issue was resolved by replacing the catheter.Information such as the background of malfunction occurrence or if the patient had cardiac conduction defect is unknown.Patient demographic information was requested but unavailable.There were no patient complications reported.Date of event is unknown.
|
|
Manufacturer Narrative
|
The device evaluation is anticipated.However, the complaint cannot be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming with the evaluation and device history results when received.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.
|
|
Manufacturer Narrative
|
Engineering evaluation was completed and concluded that a product risk assessment escalation 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.
|
|
Manufacturer Narrative
|
The reported event of pacing issue was confirmed.Continuity test found that a full open condition of the proximal circuit in y adapter.The distal circuit was found to be continuous.No open or short condition was observed in the lead wires between just distal side of y adapter and the electrodes.No visible damage or abnormality was observed from catheter body, balloon, windings, and returned syringe.The balloon inflated clear and concentric and remained inflated for 5min without leakage.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.
|
|
Search Alerts/Recalls
|