Model Number H74939148308010 |
Device Problem
Device Markings/Labelling Problem (2911)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/06/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that the balloon radiopaque marker could not be seen under fluoroscopy.The target lesion was located in the anterior tibial artery.A 3.0mm x 80mm x 150cm sterling¿ sl balloon catheter was advanced for dilatation.However, during advancement of the catheter before reaching the target vessel, the radiopaque marker was not visible under x-ray.The balloon was never inflated and the device was completely removed from the patient.The procedure was completed using another of the same device.No patient complications were reported and the patient's status was stable.
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Manufacturer Narrative
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Device evaluated by mfr: returned product consisted of a sterling balloon catheter.Microscopic and tactile inspection revealed numerous kinks in the shaft.Microscopic and visual inspection found the balloon was tightly folded.The marker bands were found to be in the correct positions and were undamaged.Inspection of the remainder of the device revealed no other damage or irregularities.There was no evidence of any damage or irregularities contributing to the reported difficulty seeing the marker band, which could not be confirmed because the clinical circumstances could not be replicated.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause was unable to be determined.(b)(4).
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Event Description
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It was reported that the balloon radiopaque marker could not be seen under fluoroscopy.The target lesion was located in the anterior tibial artery.A 3.0mm x 80mm x 150cm sterling sl balloon catheter was advanced for dilatation.However, during advancement of the catheter before reaching the target vessel, the radiopaque marker was not visible under x-ray.The balloon was never inflated and the device was completely removed from the patient.The procedure was completed using another of the same device.No patient complications were reported and the patient's status was stable.
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Search Alerts/Recalls
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