Model Number 24700 |
Device Problems
Deflation Problem (1149); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/26/2024 |
Event Type
malfunction
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Event Description
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It was reported that deflation issue occurred.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified artery.An 8.0mmx20mmx80cm (4f) sterling balloon catheter was advanced for dilatation.Upon deflation, the balloon could not be deflated properly.The device was replaced with another product and completed the procedure.No complications were reported.
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Manufacturer Narrative
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Device evaluated by mfr: the device was returned for analysis and completed the investigation.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed no damages.Microscopic examination revealed a hole to the inflation lumen 32.3cm from the hub.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found no damage to the device that would have contributed to the reported event.
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Manufacturer Narrative
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Device evaluated by mfr: the device was returned for analysis and completed the investigation.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed no damages.Microscopic examination revealed a hole to the inflation lumen 32.3cm from the hub.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found no damage to the device that would have contributed to the reported event.
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Event Description
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It was reported that deflation issue occurred.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified artery.An 8.0mmx20mmx80cm (4f) sterling balloon catheter was advanced for dilatation.Upon deflation, the balloon could not be deflated properly.The device was replaced with another product and completed the procedure.No complications were reported.It was further reported that the target lesion was located in the abdominal aorta.The deflation failure occurred when the device was tested outside the patient before use.
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Search Alerts/Recalls
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