Model Number 24672 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/18/2023 |
Event Type
malfunction
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Manufacturer Narrative
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E1: initial reporter address 1: (b)(6).E1: initial reporter phone number: (b)(6).
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Event Description
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It was reported that shaft break occurred.During unpacking of a 6.0 x 150, 135cm mustang balloon catheter, it was noticed that the balloon and the shaft was completely separated into two pieces at about 120cm from the hub.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable.
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Event Description
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It was reported that shaft break occurred.During unpacking of a 6.0 x 150, 135cm mustang balloon catheter, it was noticed that the balloon and the shaft was completely separated into two pieces at about 120cm from the hub.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable.
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Manufacturer Narrative
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D4 - lot number: updated from 29613528 to 29184873.Device evaluation by mfr: a mustang device was returned for analysis.A visual examination identified that the balloon was not subjected to positive pressure and the markerbands was still attached to the balloon section of the device.The rated burst pressure for this device as per mustang specification is 22 atmospheres.A visual examination observed no damage to the tip of the device.A visual and tactile examination found the shaft of the device to have completely detached.The break was located approximately 175mm proximal of the distal tip.Stretching damage was noted for approximately 6mm proximal from where the shaft was detached.A visual examination found no issues with the markerbands.This concludes the product analysis.(b)(6).
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Search Alerts/Recalls
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