C.R. BARD, INC. (COVINGTON) -1018233 NITINOL CORE GUIDEWIRE, .035", 3 CM, STRAIGHT, STIFF, 150 CM LENGTH; NITINOL GUIDEWIRE
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Catalog Number 150NSS35 |
Device Problem
Flaked (1246)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/10/2023 |
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 coating of the guide wire comes off and it was difficult to remove the guidewire from the patient's body.The solution was to remove it slowly and was used a different guidewire.
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Event Description
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It was reported that the coating of the guide wire comes off and it was difficult to remove the guidewire from the patient's body.The solution was to remove it slowly and was used a different guidewire.
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Manufacturer Narrative
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The reported event is confirmed cause unknown.Visual evaluation noted received 1 guidewire.Flaking was present on sample received.No occlusions or bumps were present on the guidewire that could potentially contribute towards difficulty of removing the guidewire.However, it is unknown how the guidewire interacted with patient's body.Also received one photo sample that showed top view of flaking present on guidewire.Based on photo and physical samples received the product does not meet 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." 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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Search Alerts/Recalls
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