BOSTON SCIENTIFIC CORPORATION APEX; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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Model Number 7518 |
Device Problem
Difficult to Remove (1528)
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Patient Problem
No Patient Involvement (2645)
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Event Date 05/03/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Device evaluated by mfr: returned product consisted of an apex balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There were numerous kinks.The balloon was loosely folded.The exit notch was damaged.The shaft was stretched down starting 18.5cm from the exit notch.The inner shaft was separated starting 18.5cm from the exit notch.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed that there was damage consistent with difficulty removing a mandrel or guidewire.
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Event Description
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Reportable based on device analysis completed on 12jun2020.It was reported that stylet removal difficulties were encountered.During unpacking of a 2.00mm x 12mm apex balloon catheter, it was noted that the tip of the stylet was damaged and there was difficulty in removing it.A new balloon was used and the procedure was completed.No patient serious injury or adverse event were reported and the patient's status was stable.No patient complications nor injuries were reported.However, returned device analysis revealed shaft separation.
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