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Model Number U357584 |
Device Problems
Difficult to Remove (1528); Material Rupture (1546); Detachment of Device or Device Component (2907)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 05/21/2021 |
Event Type
Injury
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Manufacturer Narrative
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As the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiry date: 08/2022).
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Event Description
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It was reported that during an angioplasty procedure, the pta balloon catheter allegedly separated and got retained in the patient's left iliac.It was further reported that the balloon was allegedly ruptured and had difficulty in retracting the balloon through the introducer sheath.Reportedly, the device was attempted to be snared from right access but unsuccessful, therefore, alternative access was obtained.However, the device was unable to be removed after several attempts.The current status of the patient is was unknown.
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Search Alerts/Recalls
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