Catalog Number EVLTPVAK |
Device Problems
Device Damaged Prior to Use (2284); Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/27/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The reported defective device has been returned to the manufacturer for a device evaluation.An investigation into the root cause for product problem is currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference :(b)(4).
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Event Description
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A territory manager reported an end user experienced an issue when using a pvak-400 micron fiber procedure kit.The fiber was found broken upon opening, unused.The procedure was completed with a new of the same device.The patient did not experience any adverse effects, harm, or require medical intervention because of this incident.
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Manufacturer Narrative
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The customer's reported complaint description of the fiber fractured was confirmed based on visual inspection of the returned fiber complaint sample.The likely root cause of the fiber fracture is handling damage but when and how this occurred cannot be definitively determined.The fiber tip is packaged such that the tip of the fiber is located under the coil wrap.The fraction location is in the middle of the fiber that would have been a coiled section.It cannot be determined if the fracture location was near the coil wrap.A potential contributing factor for the fiber fracture is the coil wrap and/or the process of end user removing the coil wrap from the fiber during the unpacking process.Manufacturing personnel 100% visually inspect devices during the packaging process.This type of fiber kink/detached damage would be noticed prior to shipment.A device history record review of the indicated packaging/assembly lots revealed no quality related issues or manufacturing deficiencies at the time of manufacture.Labeling review: the directions for use (14601411-01) which is supplied to the end user with the reported catalog number contains the following statement: warning contents supplied sterile using an ethylene oxide (eo) process.Do not use if sterile barrier is damaged.If damage is found, call your sales representative.Inspect prior to use to verify that no damage has occurred during shipping.Intended use the venacure evlt 400 m perforator and accessory vein ablation kit is intended for use in the treatment of superficial vein reflux of the greater saphenous vein associated with varicosities.The venacure evlt 400 m perforator and accessory vein ablation kit is indicated for treatment of incompetence and reflux of superficial veins in the lower extremity, and for treatment of incompetent (i.E.Refluxing) perforator veins (ipvs).Equipment handling requirements venacure evlt 400 m perforator and accessory vein ablation kit: using sterile technique open the pack, place all contents into sterile field and inspect for damage.Do not use if any component is damaged.If damage is present, contact customer service or your local representative.A review of the angiodynamics complaint system noted no adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Reference pr(b)(4).
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Search Alerts/Recalls
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