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

Model Number	788624
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Event or Problem Description
It was reported that the removal of the black wire resulted in tube breakage of the ureteral stent.
Additional Manufacturer Narrative
The reported event was confirmed however the cause was unknown.The ureteral stent was returned with the opened original packaging.One end of the pigtail was noted to be broken off and separated from the body of the stent.The tubing was observed to be going inwards at the end of the separation, this was seen when the tubing has been cut with scissors; the removal of the suture does not create the same effect.The suture hole appears to be in perfect condition.Though the event states the damage was caused by removal of the suture, the suture is not believed to have caused this pattern of separation as it would break before separating the stent into two pieces.A potential root cause for this event could be, "user error".As no patient involvement was reported the device was not used on a patient, though it is intended for treatment purposes.It was unknown if the device had met all relevant specifications.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: "suture may be cut off prior to stent placement.Remove suture prior to placement for pediatric patients." "improper handling technique can seriously weaken the stent." "exercise care.Tearing of the stent can be caused by sharp instruments." "care should be exercised when removing the stent from inner polybag so as not to cause tearing or fragmentation." "the suture may be removed prior to placement or may be removed once indwelling by using an appropriate cystoscopic instrument." corrections: d,h 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 or Problem Description
It was reported that the removal of the black wire resulted in tube breakage of the ureteral stent.

• Brand Name: BARD® INLAY® URETERAL STENT
• Common Device Name: 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13666230
• Report Number: 1018233-2022-01036
• Device Sequence Number: 20159336
• Product Code: FAD
• UDI-Device Identifier: 00801741015755
• UDI-Public: (01)00801741015755
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K983498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/17/2025
• Device Model Number: 788624
• Device Catalogue Number: 778624
• Device Lot Number: NGFR3525
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2022
• Supplement Date Received by Manufacturer: 06/02/2022
• Initial Report FDA Received Date: 03/04/2022
• Supplement Report FDA Received Date: 06/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown