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

Model Number	787426
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there were burrs at the tip of the inlay optima ureteral stent, making it unusable.The stent was not used and they inserted a new one.
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 there were burrs at the tip of the inlay optima ureteral stent, making it unusable.The stent was not used and they inserted a new one.
Additional Manufacturer Narrative
The reported event is confirmed, cause unknown.The ureteral stent was returned without the original packaging.An evaluation was completed.Photo sample was provided and the tip of the stent appeared to be mangled.The tips of the physical sample were evaluated and could be seen as defective tips.The first tip evaluated appears the tubing is twisted and caused the tube to curl up and stretch the material.The second tip evaluated appears to be going inward, there was also indentations indicating the sample was being clamped with a foreign object.Based on the appearance of the sample it could be confirmed that the sample would not pass 100% inspection in this state.The defect at the tips could not be recreated, and no defect in this manner has been seen at this facility.The ends where the defect occurred did appear to have black smudging on the outside of the stent.The dimensional requirements could not be 100% executed due to the state of the sample.The outer diameter measured 0.0621" using a laser micrometer which was within specifications.The pin gauge could not be inserted to measure the inner diameter.The guidewire for passage could not be inserted due to the damage at the tips of the sample.Although a specific cause cannot be determined, a potential root cause for this event could be, "user does not handle with care, bends sharply".As no patient involvement was reported the device was not used, however, it is intended for treatment purposes.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: "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 the inner polybag to eliminate 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 OPTIMA® URETERAL STENT WITH HYDROGLIDE¿ GUIDEWIRE
• Common Device Name: GUIDEWIRE
• 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: 15487707
• Report Number: 1018233-2022-07459
• Device Sequence Number: 13942542
• Product Code: FAD
• UDI-Device Identifier: 10801741015363
• UDI-Public: (01)10801741015363
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K043193
• 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): 02/16/2023

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: 06/28/2026
• Device Model Number: 787426
• Device Catalogue Number: 787426
• Device Lot Number: NGGQ5107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/15/2022
• Supplement Date Received by Manufacturer: 02/16/2023
• Initial Report FDA Received Date: 09/26/2022
• Supplement Report FDA Received Date: 02/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2022
• 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