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

Catalog Number 788626

Device Problem Material Fragmentation (1261)

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

Event Date 09/29/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that the shaft and the pigtail were found to be broken before the package was opened.

Event Description

It was reported that the shaft and the pigtail were found to be broken before the package was opened.

Manufacturer Narrative

The reported event was confirmed as supplier related issue.Evaluation found breakage at one of the pigtail of stent.A potential root cause for this failure mode could be, ¿defect components from supplier¿.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 1) if you measure the length of patien t s ureter and confirm that excessive coil part would be appear , consider using other stent which has different shape of tip and length.Ureteral stent s with excessive coil parts ha ve risks of knot formation at the tip of renal pelvis side during placemen t 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) uret eroarterial 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 su rgery 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.]" 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.

• Brand Name: BARD INLAY OPTIMA URETERAL STENT
• Type of Device: URETERAL STENT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 10733504
• MDR Text Key: 212997762
• Report Number: 1018233-2020-20418
• 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): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: 788626
• Device Lot Number: MYEQ0118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2020
• Date Manufacturer Received: 02/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other