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

Model Number 788426

Device Problems Material Fragmentation (1261); Device Handling Problem (3265)

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

Event Date 06/25/2023

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 when the doctor tried to insert the ureteral stent to the patient, the stent ruptured at the tail end.Therefore, the urethral stent was removed and discarded, causing no impact on the patient.The issue was detected during reuse of single use medical device.Per follow-up information received from ibc on 27jun2023, stated that information provided by sales representative was the stent was used in the patient, but the fracture occurred at the end tip of stent and not yet into the patient.No residuals in the patient.Also stated that it was mentioned in the source document "reused single use medical device", but it was wrong selection.Stent should be initial use.

Event Description

It was reported that when the doctor tried to insert the ureteral stent to the patient, the stent ruptured at the tail end.Therefore, the urethral stent was removed and discarded, causing no impact on the patient.The issue was detected during reuse of single use medical device.Per follow-up information received from ibc on 27jun2023, stated that information provided by sales representative was the stent was used in the patient, but the fracture occurred at the end tip of stent and not yet into the patient.No residuals in the patient.Also stated that it was mentioned in the source document "reused single use medical device", but it was wrong selection.Stent should be initial use.

Manufacturer Narrative

Per investigator evaluation, bd has determined that this mdr event is not reportable.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
• 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: 17313076
• MDR Text Key: 319197961
• Report Number: 1018233-2023-05104
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K043193
• 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: 09/01/2023

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: 788426
• Device Catalogue Number: 788426
• Device Lot Number: NGGX4980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/25/2023
• Initial Date FDA Received: 07/12/2023
• Supplement Dates Manufacturer Received: 09/11/2023
• Supplement Dates FDA Received: 09/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2023
• 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