MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 BARD® INLAY OPTIMA® URETERAL STENT WITH HYDROGLIDE¿ GUIDEWIRE

Catalog Number 787622

Device Problems Tear, Rip or Hole in Device Packaging (2385); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/05/2023

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

It was reported that upon opening the package, the plastic bag of the stent was found to be nearly torn, so it was not used.

Manufacturer Narrative

The reported event was confirmed ¿ cause unknown.The reported failure was able to be reproduced.Based on the evaluation, it was observed there are only stent returned for evaluation.Visual inspection noticed there was torn on the inner package of stent.The torn was looks likes exposed to the sharp object during handling the product.The exact cause of how and when the problem occurred could not be determined.A potential root cause for this failure could be due to operator error (rough handling)/sealing parameter set point below specification/ sealing machine faulty/ operator's handling method.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.The instructions for use were found adequate and states 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) uretero-arterial 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 re-sterilize 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.H3 other text : the actual/suspected device was inspected.

Event Description

It was reported that upon opening the package, the plastic bag of the stent was found to be nearly torn, so it was not used.

Manufacturer Narrative

The reported event was confirmed ¿ cause unknown.The reported failure was able to be reproduced.Based on the evaluation, it was observed there are only stent returned for evaluation.Visual inspection noticed there was tear on the inner package of stent.Tear on returned complaint sample did not have similar appearance which due exposed to sharps object.Tear looks like it was initiated by human force tearing.Evaluation concluded that the tear is a result of post manufacturing damage and is not manufacturing related.The exact cause of how and when the problem occurred could not be determined.A potential root cause for this failure could be rough handling.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." 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.

Event Description

It was reported that upon opening the package, the plastic bag of the stent was found to be nearly torn, so it was not used.

• Brand Name: BARD® INLAY OPTIMA® URETERAL STENT WITH HYDROGLIDE¿ GUIDEWIRE
• Type of Device: GUIDEWIRE
• Manufacturer (Section D): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 17183387
• MDR Text Key: 317679857
• Report Number: 1018233-2023-04603
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K043193
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 787622
• Device Lot Number: MYGT0039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/05/2023
• Initial Date FDA Received: 06/22/2023
• Supplement Dates Manufacturer Received: 07/03/2023; 07/25/2023
• Supplement Dates FDA Received: 07/07/2023; 07/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other