BOSTON SCIENTIFIC CORPORATION EMERGE; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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Model Number 7134 |
Device Problems
Leak/Splash (1354); Material Deformation (2976)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/05/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Device evaluated by mfr.: returned product consisted of the emerge balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There was contrast in the inflation lumen and blood in the guidewire lumen.The balloon was tightly folded.Inspection of the device presented numerous kinks throughout the hypotube with a complete hypotube break 49cm distal of the strain relief.The hypotube fracture surfaces were ovaled, which indicates that the device was kinked prior to separation.An inflation device filled with water was connected to the remaining distal end of the device by attaching a toughy and a stopcock to the fractured hypotube.The device was inflated to the rated burst pressure for 5 minutes.The catheter maintained constant pressure and there was no indication of any leaks or other irregularities.
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Event Description
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Reportable based on device analysis completed on 20nov2019.It was reported that balloon leak and shaft kink occurred.A 2.50mm x 20mm emerge balloon catheter was selected for use.However, during preparation, it was noticed that the balloon catheter was kinked.When pressure was exerted, the balloon was found leaking gas.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable.However, returned device analysis revealed that balloon shaft was detached/separated.
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