C.R. BARD, INC. (COVINGTON) -1018233 NICORE NITINOL GUIDEWIRE, GUIDEWIRE WITH HYDROPHILIC COATING
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Catalog Number 150NSS35 |
Device Problem
Material Fragmentation (1261)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 10/12/2023 |
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.H11: section a through f - the information provided by bd represents all 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 bd.
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Event Description
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It was reported that the user used a guide wire in a ureteral stenosis operation.Upon opening and taking out the guide wire from the package, it was found that the guide wire was broken.It did not affect the patient, but it affected the surgical process and the doctor immediately took out a new one to use and completed the operation, so that the patient's condition improved.The household and the course of surgery were affected and there was prolongation of the operation time.The type of clinical event was hand technique delayed late.
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Manufacturer Narrative
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The reported event is confirmed cause unknown.Visual evaluation noted 2 photo samples received.First photo sample zooms on the tip of the guidewire.Second photo sample shows top view of guidewire within holder sitting on top of packaging.Due to the condition of the photo sample received it is unknown if the product meets specifications.Although an exact root cause could not be determined a potential root cause could be inadequate material.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "warning: 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.Failure to comply with the warnings could result in damage to the guidewire to include, but not limited to: wire breakage, abrasion of the coating, release of guidewire fragments into the urinary system, all of which might require intervention." corrections: d.H11: section a through f - the information provided by bd represents all 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 bd.H3 other text : the actual/suspected device was inspected.
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Event Description
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It was reported that the user used a guide wire in a ureteral stenosis operation.Upon opening and taking out the guide wire from the package, it was found that the guide wire was broken.It did not affect the patient, but it affected the surgical process and the doctor immediately took out a new one to use and completed the operation, so that the patient's condition improved.The household and the course of surgery were affected and there was prolongation of the operation time.The type of clinical event was hand technique delayed late.
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Search Alerts/Recalls
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