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

Catalog Number	788624
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2023
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 the factory fault for the stent being blocked.They stated it was a factory fault and somehow the stent was blocked.It was stated that more information was required from the doctor.As per the follow up information received on 01nov2023, the event happened on the 23rd of october 2023.The stent could not feed into the guidewire.It was the bard nitinol guidewire and the stent could not feed over it, as if it was stuck.It was a once off event.
Event or Problem Description
It was reported that the factory fault for the stent being blocked.They stated it was a factory fault and somehow the stent was blocked.It was stated that more information was required from the doctor.As per the follow up information received on 01nov2023, the event happened on the 23rd of october 2023.The stent could not feed into the guidewire.It was the bard nitinol guidewire and the stent could not feed over it, as if it was stuck.It was a once off event.
Additional Manufacturer Narrative
The reported event is unconfirmed as no blockage was present in the stent.Visual requirements states to use unaided eye at 12" to 18" distance under normal room lighting unless otherwise noted.Guidewire passage is to be performed with 0.038" guidewire.When evaluating the sample, it could be seen that the sample was removed from all original packaging.There were no visual defects that could be evaluated.A 0.038" guidewire passed through the sample with no hesitation.At the time of the evaluation of the stent the guidewire that was performed while using the stent was not provided for evaluation.The guidewire used by the user was received on 12mar2024.The guidewire was provided in a large ziploc bag.The guidewire passed through the returned stent with no hesitation.Dimensional evaluation noted the guidewire was measured at 0.03240" using a thickness gauge.Photo sample evaluation noted received 2 photo samples.First photo sample shows guidewire and stent within open packaging.Second photo sample zooms in on stent and guidewire on top of product packaging.Product packaging indicates material number, lot number, and expiration date.Therefore, the complaint report could not be confirmed.No root cause could be found because the reported event was unconfirmed.Dhr review is not required as the reported event is unconfirmed.Labelling review is not required as the reported event is unconfirmed.Correction: d 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
• 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: 18150487
• Report Number: 1018233-2023-08200
• Device Sequence Number: 6747371
• Product Code: FAD
• UDI-Device Identifier: 00801741015755
• UDI-Public: (01)00801741015755
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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): 03/21/2024

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: 788624
• Device Lot Number: NGHN3374
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2023
• Supplement Date Received by Manufacturer: 03/21/2024
• Initial Report FDA Received Date: 11/16/2023
• Supplement Report FDA Received Date: 03/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2023
• 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