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

Model Number 778626

Device Problem Biocompatibility (2886)

Patient Problem Fever (1858)

Event Date 05/19/2023

Event Type  Injury  

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.

Event Description

It was reported that the customer removed the ureteral stent (778626) from the packaging box during use.Before passing the stent through the guide wire, the customer pulled apart the wire and applied a gentle transverse pull force to the stent.The stent was ruptured and replaced with a new one (778626) to continue the procedure.After operation, the patient had a fever.Since the problem had occurred at the this hospital for the third time, the doctors¿ confidence in this product had been severely impacted.The hospital asked the company to explain about the stent ruptures and hopes the company to pay more attention to this.It was unknown what medical intervention was provided for the infection.

Manufacturer Narrative

The reported event is inconclusive as no sample was returned for evaluation.Visual evaluation noted one photo sample received.Photo sample shows outer product packaging indicating product catalog number, lot number, and expiration date.The sample received cannot be evaluated for the reported event due to sample condition.Although an exact root cause could not be determined a potential root cause could be material selection.A dhr review did not show any problems or conditions that would have contributed to the reported event.The instructions for use were found adequate and state the following: "precautions: the insertion of a ureteral stent should only be done by those individuals who have comprehensive training in the techniques and risks of the procedure.Potential complications: potential complications associated with retrograde/antegrade positioning of indwelling ureteral.Stents include the following: edema; stone formation; peritonitis; extravasation; ureteral reflux; stent dislodgement; fistula formation; loss of renal function fragmentation, migration, occlusion; hemorrhage; pain/discomfort; stent encrustation; hydronephrosis; perforation of kidney, renal; ureteral erosion; infection pelvis, ureter and/or bladder; urinary symptoms".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.

Event Description

It was reported that the customer removed the ureteral stent (778626) from the packaging box during use.Before passing the stent through the guide wire, the customer pulled apart the wire and applied a gentle transverse pull force to the stent.The stent was ruptured and replaced with a new one (778626) to continue the procedure.After operation, the patient had a fever.Since the problem had occurred at the this hospital for the third time, the doctors¿ confidence in this product had been severely impacted.The hospital asked the company to explain about the stent ruptures and hopes the company to pay more attention to this.It was unknown what medical intervention was provided.

• Brand Name: BARD® INLAY® 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 17117932
• MDR Text Key: 317138959
• Report Number: 1018233-2023-04284
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 00801741014833
• UDI-Public: (01)00801741014833
• 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: 11/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 778626
• Device Catalogue Number: 778626
• Device Lot Number: NGGV5132
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/19/2023
• Initial Date FDA Received: 06/13/2023
• Supplement Dates Manufacturer Received: 11/03/2023
• Supplement Dates FDA Received: 11/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2022
• 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