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

Model Number 788626

Device Problem Incorrect Measurement (1383)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/28/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that the proximal tip of the stent looks snub nosed like not tapered through the cystoscope.Another physician thought they have a fat end instead of a gentle taper like they are used to.Noted that the stent was removed and tagged as defective.As per follow up received on 05jun2021, inlay optima stent failed during the procedure.No patient injury was caused.No medical intervention was reported.

Manufacturer Narrative

The reported event is unconfirmed as the device met specifications.The used ureteral stent and suture were returned in the original packaging.No visible defects were noted on the returned sample and both ends were observed to be tipped (tapered).The device was used for treatment purposes.As the device met product specifications there does not appear to be a relationship between the event and the device.As the reported event is unconfirmed, a dhr review is not required.As the reported event is unconfirmed, a label/packaging review is not required.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.

Event Description

It was reported that the proximal tip of the stent looks snub nosed like not tapered through the cystoscope.Another physician thought they have a fat end instead of a gentle taper like they are used to.Noted that the stent was removed and tagged as defective.As per follow up received on 05jun2021, inlay optima stent failed during the procedure.No patient injury was caused.No medical intervention was reported.

• Brand Name: BARD® INLAY OPTIMA® URETERAL STENT
• Type of Device: 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 12050933
• MDR Text Key: 257823288
• Report Number: 1018233-2021-03739
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 00801741015762
• UDI-Public: (01)00801741015762
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043193
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/19/2021

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
• Device Operator: Health Professional
• Device Model Number: 788626
• Device Catalogue Number: 788626
• Device Lot Number: NGFP0947
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/01/2021
• Initial Date FDA Received: 06/23/2021
• Supplement Dates Manufacturer Received: 11/19/2021
• Supplement Dates FDA Received: 12/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other