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

Model Number 777620

Device Problem Incorrect Measurement (1383)

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

Event Date 05/18/2023

Event Type  malfunction  

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.H3 other text : the device was not returned.

Event Description

It was reported that the survey respondent stated no, the guidewire did not support stent placement procedure because difficult to retrieve in relation to inlay ureteral stent with hydroglide guidewire 6 fr 20cm.Per additional information via email on 18may2023,it was reported that the survey respondent stated no, the guidewire did not support stent placement procedure because because too small in relation to inlay ureteral stent with hydroglide guidewire 6 fr 20cm.

Event Description

It was reported that the survey respondent stated no, the guidewire did not support stent placement procedure because difficult to retrieve in relation to inlay ureteral stent with hydroglide guidewire 6 fr 20cm.Per additional information via email on 18may2023,it was reported that the survey respondent stated no, the guidewire did not support stent placement procedure because too small in relation to inlay ureteral stent with hydroglide guidewire 6 fr 20cm.

Manufacturer Narrative

The reported event is inconclusive as no sample was returned for evaluation.Although an exact root cause could not be determined a potential root cause could be material selection.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "directions for use: 1.Determine the proper stent length for the patient.This is generally calculated from the baseline pyelogram.Accurate measurements will optimize drainage efficiency and patient comfort.Submerge stent in sterile water to activate the coating." 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 device was not returned.

• Brand Name: BARD® INLAY® URETERAL STENT WITH HYDROGLIDE¿ GUIDEWIRE
• 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 17106528
• MDR Text Key: 317685945
• Report Number: 1018233-2023-04235
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 10801741014526
• UDI-Public: (01)10801741014526
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K983498
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/06/2023

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: 777620
• Device Catalogue Number: 777620
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/18/2023
• Initial Date FDA Received: 06/12/2023
• Supplement Dates Manufacturer Received: 11/07/2023
• Supplement Dates FDA Received: 11/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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