Model Number 7162 |
Device Problem
Break (1069)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 07/18/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).
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Event Description
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It was reported that shaft break occurred.A 2.75mm x 12mm emerge balloon catheter was selected for use; however, it was noted that the shaft broke approximately 25cm from the hub.There were no patient complications nor injuries reported.
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Manufacturer Narrative
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Initial reporter city: (b)(6).Device evaluated by mfr.: returned product consisted of an emerge balloon catheter in two pieces.The hypotube, outer shaft, inner shaft, balloon and tip were visually and microscopically examined.The hypotube was completely separated 26cm from the hub.The hypotube fracture surface was ovaled and torn, which suggests the device was kinked prior to separation.There are numerous hypotube and shaft kinks.The tip is damaged.Inspection of the remainder of the device presented no other damage or irregularities.
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Event Description
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It was reported that shaft break occurred.A 2.75mm x 12mm emerge balloon catheter was selected for use; however, it was noted that the shaft broke approximately 25cm from the hub.There were no patient complications nor injuries reported.
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Event Description
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It was reported that shaft break occurred.A 2.75mm x 12mm emerge balloon catheter was selected for use; however, it was noted that the shaft broke approximately 25cm from the hub.There were no patient complications nor injuries reported.It was further reported that the shaft broke outside the patient and the procedure was completed with another emerge balloon.The patient was fine.
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Manufacturer Narrative
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E1: initial reporter city: (b)(6).Device evaluated by mfr.:returned product consisted of an emerge balloon catheter in two pieces.The hypotube, outer shaft, inner shaft, balloon and tip were visually and microscopically examined.The hypotube was completely separated 26cm from the hub.The hypotube fracture surface was ovaled and torn, which suggests the device was kinked prior to separation.There are numerous hypotube and shaft kinks.The tip is damaged.Inspection of the remainder of the device presented no other damage or irregularities.
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Search Alerts/Recalls
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