Model Number H7493926708320 |
Device Problems
Break (1069); Detachment Of Device Component (1104)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/23/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
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Event Description
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It was reported that tip detachment occurred.After a stent was placed, a 3.25mm x 8mm nc emerge® balloon catheter was advanced for post-dilation.However, it was noted that the balloon tip broke off.The broken pieces were retrieved and the procedure was completed.No patient complications were reported and the patient's status was fine.
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was further reported that the target lesion was 90% stenosed, located in the heavily calcified with non-serious tortuosity right coronary artery.The 3.25mm x 8mm nc emerge balloon catheter was trying to cross the lesion and was never inflated when the shaft broke.The guide wire, guide extension catheter, and guide catheter were removed and everything came out without snaring.
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Event Description
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It was further reported that the target lesion was 90% stenosed, located in the heavily calcified with non-serious tortuosity right coronary artery.The 3.25mm x 8mm nc emerge balloon catheter was trying to cross the lesion and was never inflated when the shaft broke.The guide wire, guide extension catheter, and guide catheter were removed and everything came out without snaring.
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Manufacturer Narrative
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Device evaluated by mfr.: returned product consisted of an nc emerge balloon catheter in two pieces.The balloon was loosely folded with blood in the lumen and balloon.The outer shaft, inner shaft, balloon and tip were microscopically examined.The hypotube was completely separated 70.7cm from the hub.The fracture faces were oval as if kinked prior to separation.There are numerous hypotube and shaft kinks.There was no evidence of any material or manufacturing deficiencies contributing to the damage.The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).
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Search Alerts/Recalls
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