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

Catalog Number 788624

Device Problem Accessory Incompatible (1004)

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

Event Date 12/06/2023

Event Type  malfunction  

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.It is unknown whether the device had met relevant specifications.The potential root cause for this failure mode could be defects component from supplier.The dhr review could not be performed without a lot number.The instructions for use were found adequate and states the following: [warnings].1.Method for use.(1) when using the multi-length type, use should be avoided in the following cases.1) measure the length of patient¿s ureter and confirm that excessive coil parts will not be formed.Consider use of other stent lengths depending on risk.Ureteral stents with excessive coil parts have risks of knot formation at the tip of the renal pelvis side during placement or removal.1).2) if any resistance is felt during removal, confirm the cause of the resistance under 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 resterilized.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.] [shape, configuration and principles].Bard inlay® stent tri-pak® comprises the following components.1.Inlay® ureteral stent.The inlay ureteral stent is a double pigtail ureteral stent with monofilament suture loop.Attached to aid in stent removal.The stent is available in two forms: a single size or a customized multi-length size.Some of the single size type have no side hole.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 when a patient attempts to use a tiger tail ureteral catheter inside an optima stent for stenting in the operating room, the adapter was difficult to move, making the procedure difficult.

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 dhr review could not be performed without a lot number.The instructions for use were found adequate and state the following: "[warnings] 1.Method for use (1) when using the multi-length type, use should be avoided in the following cases.1) measure the length of patient¿s ureter and confirm that excessive coil parts will not be formed.Consider use of other stent lengths depending on risk.Ureteral stents with excessive coil parts have risks of knot formation at the tip of the renal pelvis side during placement or removal.1) 2) if any resistance is felt during removal, confirm the cause of the resistance under 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 resterilized.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.] [shape, configuration and principles] bard inlay® stent tri-pak® comprises the following components.1.Inlay® ureteral stent the inlay ureteral stent is a double pigtail ureteral stent with monofilament suture loop attached to aid in stent removal.The stent is available in two forms: a single size or a customized multi-length size.Some of the single size type have no side hole." 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 when a patient attempts to use a tiger tail ureteral catheter inside an optima stent for stenting in the operating room, the adapter was difficult to move, making the procedure difficult.The exact material number is unknown but should be 881624, 881626, 889426, 889624 or 889626.

• 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
• 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: 18400257
• MDR Text Key: 331511468
• Report Number: 1018233-2023-09251
• 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
• Report Date: 02/06/2024
• 2 Devices were Involved in the Event: 1 2

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: 788624
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2023
• Initial Date FDA Received: 12/27/2023
• Supplement Dates Manufacturer Received: 02/06/2024
• Supplement Dates FDA Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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