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

Catalog Number 787426

Device Problem Material Twisted/Bent (2981)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/08/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Event Description

It was reported that the tip part of the pig tail was entwined prior to use.The device was not used.

Manufacturer Narrative

The reported event was confirmed however the cause was unknown.The product had caused the reported failure.The sample was evaluated and observed the stent received did not had a double pigtail.The stent straightener could be moved around the stent.The cause of one of the end stent was not in coil position or no double pigtail observed on returned stent.How and when the problem was occurred could not be determined.A potential root cause for this failure mode could be due to the defect component from the supplier or user related or mishandling the product.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.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." h11:section a through f - the information provided by bd represents all of 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 the tip part of the pigtail was entwined prior to use.It was noted that the device was not used.

• Brand Name: BARD INLAY OPTIMA URETERAL STENT WITH HYDROGLIDE GUIDEWIRE
• Type of Device: URETERAL STENT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11164345
• MDR Text Key: 226631034
• Report Number: 1018233-2020-22466
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• PMA/PMN Number: K043193
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/22/2021

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 Expiration Date: 03/28/2023
• Device Catalogue Number: 787426
• Device Lot Number: MYET3331
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2021
• Initial Date Manufacturer Received: 12/23/2020
• Initial Date FDA Received: 01/13/2021
• Supplement Dates Manufacturer Received: 06/22/2021
• Supplement Dates FDA Received: 07/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other