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

Model Number	778726
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that ureteral stent was found to be ruptured when the user was beginning to insert the stent during operation once the package was opened.The stent was not used, causing no adverse impact on the patient.
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 ureteral stent was found to be ruptured when the user was beginning to insert the stent during operation once the package was opened.The stent was not used, causing no adverse impact on the patient.
Additional Manufacturer Narrative
The reported event is confirmed, cause unknown.Th ureteral stent with suture and push catheter was returned in the opened original packaging.An evaluation of the physical sample was completed.A photo sample was submitted showing the proximal pigtail completely broken off the body of the stent.Visual evaluation of the physical sample confirmed the separation at the proximal pigtail; the material did not appear to be stretched or discolored.The suture appeared to be clamped and damaged, possibly from the same force that caused the stent to break.The sample passed all dimensional requirements the outer diameter was measured with a laser micrometer and found to be 0.0926" and 0.0911", the tip inner diameter and tube inner diameter were measured with a pin gauge and found to be 0.043" and 0.053", respectively.A 0.038" guidewire passed through the sample with no resistance.Though a specific cause cannot be determined, based on the risk document a potential root cause for this event could be, "inappropriate package design".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: "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." 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
• Common Device Name: U
• 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: 16691175
• Report Number: 1018233-2023-02356
• Device Sequence Number: 12611706
• Product Code: FAD
• UDI-Device Identifier: 00801741014901
• UDI-Public: (01)00801741014901
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K983498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2023

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: 06/14/2026
• Device Model Number: 778726
• Device Catalogue Number: 778726
• Device Lot Number: NGFX2178
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/16/2023
• Supplement Date Received by Manufacturer: 05/26/2023
• Initial Report FDA Received Date: 04/06/2023
• Supplement Report FDA Received Date: 05/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2021
• 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