Catalog Number 786700 |
Device Problem
Incomplete or Missing Packaging (2312)
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Patient Problem
No Information (3190)
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Event Date 07/06/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
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Event Description
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It was reported that there was no stent in the inlay optima box.
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Manufacturer Narrative
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Received 1 inlay optima ureteral stent kit.The reported event was confirmed; however, the cause is unknown.Per visual inspection, the stent wad missing from the package the device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: "inspect all guidewires for damage prior to use.Bending or kinking during or prior to placement could damage the guidewire.Do not attempt to use the guidewire if it has been damaged.Use of a damaged wire may result in damage to the urinary tract.Do not reshape the guidewire by any means.Attempting to reshape the guidewire may cause damage resulting in release of fragments into the urinary tract.Failure to exercise proper caution may result in damage to the urinary tract.Do not manipulate or remove the guidewire through a metal cannula or needle.This may result in destruction/separation of the outer jacket of the wire requiring retrieval.Do not use retrieval device while the guidewire is in placer; to do so may cause damage to the guidewire.Avoid contact with sharp edges as this may cause damage to the polyurethane jacket requiring retrieval.Attention should be paid to guidewire movement in the urinary tract.Before a guidewire is moved or torqued, tip movement should be examined under direct vision or fluoroscopy.Do not advance or withdraw a guidewire when resistance is encountered as perforation could occur.Sufficient guidewire length must remain exposed to maintain a firm grip on guidewire at all times." (b)(4).
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Event Description
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It was reported that there was no stent in the inlay optima box.
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Search Alerts/Recalls
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