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

Model Number 777626

Device Problems Flaked (1246); Device Contamination with Chemical or Other Material (2944)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/02/2023

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 white grease was found upon unpacking the ureteral stent.The surgery time was prolonged and surgery schedule by health care professional was affected.

Manufacturer Narrative

The reported event was confirmed and the cause was unknown.Although a specific cause could not be determined, potential root cause for this event could be inadequate material selection, and/or bonding between layers, degradation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "inspect all guidewires for damage prior to use.Bending or kinking during or prior to placement could damage the guidewire.Do not attempt to use the guidewire if it has been damaged.Use of a damaged wire may result in damage to the urinary tract." "do not reshape the guidewire by any means.Attempting to reshape the guidewire may cause damage resulting in release of fragments into the urinary tract.Failure to exercise proper caution may result in damage to the urinary tract." "do not manipulate or remove the guidewire through a metal cannula or needle.This may result in destruction/separation of the outer jacket of the wire requiring retrieval." 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 inspected.

Event Description

It was reported that white grease was found upon unpacking the ureteral stent.The surgery time was prolonged and surgery schedule by health care professional was affected.

• 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: 16617987
• MDR Text Key: 312046601
• Report Number: 1018233-2023-02034
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K983498
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/26/2023

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: 777626
• Device Catalogue Number: 777626
• Device Lot Number: NGGV2068
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/02/2023
• Initial Date FDA Received: 03/27/2023
• Supplement Dates Manufacturer Received: 06/26/2023
• Supplement Dates FDA Received: 07/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2022
• 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