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

Catalog Number	777628
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2024
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.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 or Problem Description
It was reported that when using guidewire during the operation, it was found that the middle part of double-j was ruptured, causing the guidewire to penetrate.
Additional Manufacturer Narrative
The reported event is unconfirmed as the product meets specifications.Visual requirements states to "use unaided eye at 12" to 18" distance under normal room lighting, unless otherwise noted.When evaluating the sample, it could be seen that it had been removed from all packaging, and the suture was removed from the stent.The reported rupture of the pigtail could be located.Dimensional requirements states the od to be 0.079" plus or minus 0.002", guidewire to be 0.038" plus or minus 0.002", and tip id to be 0.043" plus or minus 0.002".The sample passed all the dimensional requirements.The od was measured 0.0799" using a laser micrometer.A 0.038" guidewire passed through the sample with no hesitation.The tip id was measured using 0.043" pin gauge.The defect reported could not be confirmed.No root cause could be found because the reported event was unconfirmed.A dhr reviews was not required as the reported event was unconfirmed.Labelling review was not required as the reported event was unconfirmed.Udi format updated with available product information per gudid.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 or Problem Description
It was reported that when using guidewire during the operation, it was found that the middle part of double-j was ruptured, causing the guidewire to penetrate.

• Brand Name: BARD® INLAY® URETERAL STENT WITH HYDROGLIDE¿ GUIDEWIRE
• 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 19566938
• Report Number: 1018233-2024-03606
• Device Sequence Number: 6140533
• Product Code: FAD
• UDI-Device Identifier: 10801741014564
• UDI-Public: (01)10801741014564(11)231031(17)270428(10)NGHX0516
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2024

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 Catalogue Number: 777628
• Device Lot Number: NGHX0516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2024
• Supplement Date Received by Manufacturer: 09/13/2024
• Initial Report FDA Received Date: 06/19/2024
• Supplement Report FDA Received Date: 09/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2023
• 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