Catalog Number PCF050300130 |
Device Problem
Material Twisted/Bent (2981)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/28/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Patient weight reported as (b)(6).If information is provided in the future, a supplemental report will be issued.
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Event Description
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Physician used a pacific xtreme device with a 6fr sheath and 0.018 wire during treatment of a 30 cm lesion in the patients right full superficial femoral artery (sfa) and popliteal arteries of diameter 5 mm.Severe calcification is reported but no tortuosity.Crossover procedure.Lesion exhibited 90-100% stenosis.Embolic protection was not used.No damage noted to device or packaging prior to use.Ifu was followed.Device prepped without issue.The device was not passed through a previously deployed stent.No resistance was felt during advancement and not excessive force was used.A manometer was used with 50/50 fluid for balloon inflation.It is reported that 2 twists were evident on the balloon.The device was replaced with another pacific xtreme to complete the procedure.No patient injury reported.
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Manufacturer Narrative
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Image review: a single photograph of a cine image was received for analysis.The image is of a pta device within a vessel.Two balloon twists are present in the pta device.Product analysis: the pacific xtreme pta balloon catheter was received for evaluation.Two zones of witness marks from inflation twists were noted in the balloon chamber material.The twisting / ¿candy wrapper¿ is located 97mm and 157mm proximal of the catheter¿s distal tip.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Additional information: the twist occurred during first inflation of the balloon.The device was safely removed from the patient.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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