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

Model Number 777626

Device Problem Material Too Rigid or Stiff (1544)

Patient Problem Pain (1994)

Event Date 05/24/2023

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 on (b)(6) 2023, upon doctor's advice, the ureteral stent tube (double j tube) was used to perform holmium laser lithotripsy on the patient for ureteral calculi.On may 24, waist and abdomen pain occurred, and bladder irritation was obvious.So the stent was removed and then the patient was discharged from the hospital.According to the event cause analysis, the stent material was too hard and irritating.

Event Description

It was reported that on (b)(6) 2023, upon doctor's advice, the ureteral stent tube (double j tube) was used to perform holmium laser lithotripsy on the patient for ureteral calculi.On (b)(6), waist and abdomen pain occurred, and bladder irritation was obvious.So the stent was removed and then the patient was discharged from the hospital.According to the event cause analysis, the stent material was too hard and irritating.

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 part geometry.The device was not returned for evaluation.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: "precautions: improper handling technique can seriously weaken the stent.Acute bending or overstressing during placement could result in subsequent separation of the stent at the point of stress after a prolonged indwelling period." 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: 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: 17191814
• MDR Text Key: 317818990
• Report Number: 1018233-2023-04638
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 10801741014557
• UDI-Public: (01)10801741014557
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/09/2023

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: NGGX4107
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2023
• Initial Date FDA Received: 06/23/2023
• Supplement Dates Manufacturer Received: 11/09/2023
• Supplement Dates FDA Received: 11/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2022
• 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