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Model Number 992081 |
Device Problem
Positioning Failure (1158)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/06/2023 |
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.H3 other text : the device was not returned.
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Event Description
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It was reported that a physician stated in an online survey that they were not able to successfully place the working sheath.The physician was not able to successfully dilate the nephrostomy tract for the device 992081 - x-force® 8mm x 17cm renal sheath, clear, sterile because the access was difficult.Per additional information received from ibc on 14jun2023, stated that the customer would like to update the initial reported event.The corrected event was that the physician stated in an online survey that they were not able to successfully place the working sheath.The physician was not able to successfully place the working sheath for the device 992081 - x-force® 8mm x 17cm renal sheath, clear, sterile because the access was difficult.
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Event Description
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It was reported that a physician stated in an online survey that they were not able to successfully place the working sheath.The physician was not able to successfully dilate the nephrostomy tract for the device 992081 - x-force® 8mm x 17cm renal sheath, clear, sterile because the access was difficult.As per additional information received from ibc on 14jun2023, stated that the customer would like to update the initial reported event.The corrected event was that the physician stated in an online survey that they were not able to successfully place the working sheath.The physician was not able to successfully place the working sheath for the device 992081 - x-force® 8mm x 17cm renal sheath, clear, sterile because the access was difficult.
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Manufacturer Narrative
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The reported event is inconclusive as no sample was returned for evaluation.Although an exact root cause could not be determined a potential root cause could be beveled tip too blunt.The dhr review is not required as no lot number was reported.The instructions for use were found adequate and states the following: precautions: · only a physician who has an understanding of the clinical applications, technical principles and risks associated with balloon dilation of a nephrostomy tract should use this device.Directions for use: establishment of a percutaneous nephrostomy tract and renal dilation should always be performed under fluoroscopic control.1.Percutaneous access is established and a guidewire passed into a secure location within the intra-renal system.If feasible, the guidewire should be passed down the ureter and into the bladder.2.Dilation of the tract to the desired size should be performed using an x-force¿ nephrostomy balloon dilation catheter.3.Once the tract is established, the sheath is passed over the dilation device and positioned as desired.4.Remove the dilation instrument from within the sheath, maintaining both the sheath and guidewire in position.5.The guidewire may now be secured in the guidewire notch.6.The procedure may now be performed through the sheath.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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