C.R. BARD, INC. (COVINGTON) -1018233 BARD® INLAY OPTIMA® URETERAL STENT WITH HYDROGLIDE¿ GUIDEWIRE
|
Back to Search Results |
|
Catalog Number 787624 |
Device Problem
Nonstandard Device (1420)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/29/2023 |
Event Type
malfunction
|
Event Description
|
It was reported that the catheter itself was stretched when the tiger tail adaptor did not work, and the catheter was tried to be moved by force.
|
|
Manufacturer Narrative
|
The reported event was inconclusive because no sample was returned.It is unknown whether the device had met relevant specifications.It was unknown whether the product had caused the reported failure.The potential root cause for this failure mode could be defects component from supplier.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "[warnings].1.Method for use.(1)when using the multi-length type stent, it should be avoided in the following cases.1)if you measure the length of patient¿s ureter and confirm that excessive coil part would be appear , consider using other stent which has different shape of tip and length.Ureteral stents with excessive coil part shave risks of knot formation at the tip of renal pelvis side during placement or removal.1) 2) if any resistance is felt during removal, confirm the cause of the resistance with fluoroscopy and take remedial action to solve the problem.Excessive force during removal may lead to damage of the renal pelvis and/or ureter.(2) ureteroarterial fistula may be formed between the ureter and the aorta or the iliac artery and result in massive hemorrhage at the replacement of the ureteral stent if a ureteral stent is placed for a long term in a patient who has undergone the intrapelvic surgery or irradiation.Therefore, carefully monitor the condition of the patient, and in the event of acknowledging bleeding from the urethra, perform retrograde pyelography or angiography, and provide appropriate care.[contraindications].1.Method for use.(1)do not reuse.(2)do not resterilize.2.Applicable patients.Do not use for the woman who is pregnant or may become pregnant.[to avoid radiation exposure on pre-born baby from x-ray.] insertion of the guidewire.1)remove the guidewire from the packaging,together with the guidewire holder.2)prior to removing the guidewire from the guidewire holder, inject sterile water through the port to activate the hydrophilic coating.3) remove the guidewire from the guidewire holder.Before using the guidewire, confirm the surface slides well when removing it from the holder.If you feel any resistance, do not force it, and inject the normal saline solution into the holder again, then try pulling it out once more.4) insert the guidewire either through the working channel of an endoscope or percutaneously, with the soft end of the guidewire first.5) advance the guidewire into the desired position until the tip is in the renal pelvis.Continuously confirm guidewire position either visually or under fluoroscopy." 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.
|
|
Event Description
|
It was reported that the catheter itself was stretched when the tiger tail adaptor did not work, and the catheter was tried to be moved by force.As per the follow up information received on (b)(6)2023, the customer confirmed that the lot of stent outer box was myhq1817 and the lot of tiger tail packaging was myhu3865.
|
|
Manufacturer Narrative
|
The reported event was inconclusive because no sample was returned.It is unknown whether the device had met relevant specifications.It was unknown whether the product had caused the reported failure.The potential root cause for this failure mode could be defects component from supplier.The device was not returned for evaluation.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: "[warnings] 1.Method for use (1)when using the multi-length type stent, it should be avoided in the following cases.1)if you measure the length of patient¿s ureter and confirm that excessive coil part would be appear , consider using other stent which has different shape of tip and length.Ureteral stents with excessive coil part shave risks of knot formation at the tip of renal pelvis side during placement or removal.1) 2) if any resistance is felt during removal, confirm the cause of the resistance with fluoroscopy and take remedial action to solve the problem.Excessive force during removal may lead to damage of the renal pelvis and/or ureter.(2) ureteroarterial fistula may be formed between the ureter and the aorta or the iliac artery and result in massive hemorrhage at the replacement of the ureteral stent if a ureteral stent is placed for a long term in a patient who has undergone the intrapelvic surgery or irradiation.Therefore, carefully monitor the condition of the patient, and in the event of acknowledging bleeding from the urethra, perform retrograde pyelography or angiography, and provide appropriate care.[contraindications] 1.Method for use (1)do not reuse.(2)do not resterilize 2.Applicable patients do not use for the woman who is pregnant or may become pregnant.[to avoid radiation exposure on pre-born baby from x-ray.] insertion of the guidewire 1)remove the guidewire from the packaging,together with the guidewire holder.2)prior to removing the guidewire from the guidewire holder, inject sterile water through the port to activate the hydrophilic coating.3) remove the guidewire from the guidewire holder.Before using the guidewire, confirm the surface slides well when removing it from the holder.If you feel any resistance, do not force it, and inject the normal saline solution into the holder again, then try pulling it out once more.4) insert the guidewire either through the working channel of an endoscope or percutaneously, with the soft end of the guidewire first.5) advance the guidewire into the desired position until the tip is in the renal pelvis.Continuously confirm guidewire position either visually or under fluoroscopy." 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 device was not returned.
|
|
Search Alerts/Recalls
|
|
|