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

Catalog Number 777624

Device Problem Material Fragmentation (1261)

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

Event Date 11/16/2023

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 the endoscope showed that the ureteral stent had a crack at one end.

Event Description

It was reported that the endoscope showed that the ureteral stent had a crack at one end.

Manufacturer Narrative

The reported event is confirmed cause unknown.Visual evaluation noted the sample was provided in a large ziploc bag with the original bard pouch.Dimensional evaluation noted dimensional requirements per cd-7068-xx state the od to be 0.079" ± 0.002", tip id to be 0.043" ± 0.002" , and guidewire to be 0.038" ± 0.001".When evaluating the sample, a separation could be located from the suture port hole to the end of the stent.This separation is seen when the suture is pulled from the stent; however, the suture was not provided for evaluation.The od was measured at 0.0793" using a laser micrometer.The tip id was measuring a using a 0.043" pin gauge.A 0.038" guidewire passed through the sample without hesitation.Also received 3 photo samples.First photo sample shows top view of sorbafix packaging.Second photo sample shows packaging label of sorbafix including product catalog number, batch number, and expiration date.Fourth photo sample shows 4 small black screws on green background.Root cause could not be identified.Although a root cause could not be definitively identified, based on the risk documentation review, a potential root cause for this type of failure could be user does not handle with care, bends sharply.However, there was insufficient information to confirm this potential root cause.The dhr review did not show any problems or conditions that would have contributed to the reported event.The instructions for use were found adequate and states the following: "avoid improper handling of stent such as bending, kinking, tearing, etc.Misuse could damage the overall integrity of the stent." "care should be exercised when removing the stent from inner polybag so as not to cause tearing or fragmentation." "the insertion of a ureteral stent should only be done by those individuals who have comprehensive training in the techniques and risks of the procedure." 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.

• Brand Name: BARD® INLAY® URETERAL STENT WITH HYDROGLIDE¿ GUIDEWIRE
• 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: 18283097
• MDR Text Key: 329945348
• Report Number: 1018233-2023-08791
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 10801741014540
• UDI-Public: (01)10801741014540
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K983498
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 777624
• Device Lot Number: NGGX4108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2022
• 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