Model Number 096F6P |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/23/2023 |
Event Type
malfunction
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Event Description
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It was reported that a swan ganz balloon dislodged from the catheter during a procedure in the cath lab.The patient was admitted and being catheterized for further diagnosis and treatment of chronic systolic heart failure.Upon first pass into the heart, the balloon was inflated and wedged.The balloon was visible under fluoroscopy.The catheter was then removed and reinserted for a second pass.Upon attempting to inflate and wedge, no balloon was visible under fluoroscopy after second insertion.The catheter was removed and there was no visible balloon.Per hospital report, there were no visible evidence of foreign material in patient vasculature at any point during the procedure, which lead the staff to believe the piece of balloon was caught in the sheath.The patient did not have any adverse event or injury related to the procedure and remained hospitalized for further care as the patient required a pacemaker.The sales rep was able to observe the swan and it appeared as if the balloon was completely sheared off.There were no fragments remaining on the catheter.Information of the introducer brand or size was unknown.
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Manufacturer Narrative
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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.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.
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Manufacturer Narrative
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Per follow up with customer, risk management at the hospital refused to return catheter to edwards.Without return of the unit, it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.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.
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Search Alerts/Recalls
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