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

Model Number 787624

Device Problem Accessory Incompatible (1004)

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

Event Date 11/24/2022

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 quality department reported failure of ureteral stent during the left endoscopic ureterolithotomy procedure.When entering the double j catheter and positioning it on the guide, it was evident that it could not be advanced despite having the equipment and the guide in the proper position.It was observed that the distal end folds back on itself in the form of an accordion.When extracting the catheter, it shows deterioration and angulation of the same.Despite multiple attempts, it was not possible to advance the catheter, so the ordering of the procedure requests another element of the same brand and reference, noting that it works correctly and did not present complications.For this reason, the customer requested to review the item under warranty control.

Event Description

It was reported that the quality department reported failure of ureteral stent during the left endoscopic ureterolithotomy procedure.When entering the double j catheter and positioning it on the guide, it was evident that it could not be advanced despite having the equipment and the guide in the proper position.It was observed that the distal end folds back on itself in the form of an accordion.When extracting the catheter, it shows deterioration and angulation of the same.Despite multiple attempts, it was not possible to advance the catheter, so the ordering of the procedure requests another element of the same brand and reference, noting that it works correctly and did not present complications.

Manufacturer Narrative

The reported event is unconfirmed as the failure could not be reproduced.The ureteral stent was returned with the original packaging.An evaluation of the physical sample was completed by future matrix.No manufacturing issues or non-conformances were noted during review of the dhr that could have caused or contributed to the reported event.As the reported event is unconfirmed, a label/packaging review is not required.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
• Type of Device: 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: 15958668
• MDR Text Key: 307899846
• Report Number: 1018233-2022-09459
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 10801741015431
• UDI-Public: (01)10801741015431
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K043193
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/10/2023

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
• Device Operator: Health Professional
• Device Model Number: 787624
• Device Catalogue Number: 787624
• Device Lot Number: NGFZ2772
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/24/2022
• Initial Date FDA Received: 12/12/2022
• Supplement Dates Manufacturer Received: 04/11/2023
• Supplement Dates FDA Received: 04/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2022
• 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