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

Model Number	788726
Medical Device Problem Codes	Accessory Incompatible (1004); Nonstandard Device (1420)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2020
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.The device was not returned.
Event or Problem Description
It was reported that as the pigtail of the inlay optima was not rolled up, the surgeon could not insert it into the ureter.Per additional information via ibc on 26nov2020, pigtail shape of the stent not rolled up like how it is supposed to looks originally.Defective device notice once it is out from packaging.Therefore this is not used in the surgery.
Event or Problem Description
It was reported that as the pigtail of the inlay optima was not rolled up, the surgeon could not insert it into the ureter.Per additional information via email from ibc on 26nov2020, pigital shape of the stent not rolled up like how it is supposed to looks originally.Defective device notice once it is out from packaging.Therefore this is not used in the surgery.
Additional Manufacturer Narrative
The reported event was confirmed cause unknown.1 sample was confirmed to exhibit the reported failure in the photo sample.It is unknown whether the device had met relevant specifications.The product was to be used for treatment purposes.It was unknown whether the product had caused the reported failure.A potential root cause for this failure could be "incorrect part orientation/placement design".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labeling review is not required as the reported event is unlikely to be caused by the user.Corrections: d,h h11: section a through f - the information provided by bard represents all of 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 bard.H3 other text : the actual/suspected device was evaluated.

• 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
• MDR Report Key: 11008917
• Report Number: 1018233-2020-21680
• Device Sequence Number: 14576982
• Product Code: FAD
• UDI-Device Identifier: 00801741015847
• UDI-Public: (01)00801741015847
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K043193
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2021

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: 04/02/2024
• Device Model Number: 788726
• Device Catalogue Number: 788726
• Device Lot Number: NGEQ4172
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2020
• Initial Date Received by Manufacturer: 11/23/2020
• Supplement Date Received by Manufacturer: 09/28/2021
• Initial Report FDA Received Date: 12/15/2020
• Supplement Report FDA Received Date: 10/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other