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

Catalog Number 787426

Device Problem Disconnection (1171)

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

Event Date 11/07/2023

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.

Event Description

It was reported that the stent was disconnected during percutaneous nephroscopy after unpacking and it could not be used.

Manufacturer Narrative

The reported event is confirmed cause unknown.Visual requirements states to use unaided eye at 12" to 18" distance under normal room lighting unless otherwise noted.When evaluating the sample it could be seen that the separation was removed from all packaging including the perforated bag.The separation occurred at the distal pigtail.The separation appears to be cut due to no stretching or discoloration of the material.No other visual defects were evaluated.Dimensional evaluation noted dimensional requirements states the od is to be 0.061" ± 0.002", tip id to be 0.039" ± 0.002" guidewire to be 0.035" ± 0.001", and tube id to be 0.040" +0.002" -0.001".The sample passed all the dimensional requirements.The od measured at 0.616" and 0.0608" using a laser micrometer.The tip id was measured using a 0.039" pin gauge.A 0.035" guidewire passed through the sample with no hesitation.The tube id where the separation occurred was measured using a 0.040" pin gauge.Photo sample evaluation noted received 1 photo sample showing top view of catheter which showcases one end of the pigtail separated from the rest of the catheter.Root cause could not be identified.Although a root cause could not be definitively identified, a potential root cause for this type of failure could be user does not handle with care, bends sharply.However, there was insufficient information to confirm this potential root cause.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: "avoid improper handling of stent such as bending, kinking, tearing, etc.Misuse could damage the overall integrity of the stent." "care should be exercised when removing the stent from inner polybag so as not to cause tearing or fragmentation." "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." 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 during percutaneous nephroscopy, the stent was disconnected while unpacking and it could not be used.

• Brand Name: BARD® INLAY OPTIMA® 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: 18209515
• MDR Text Key: 329017589
• Report Number: 1018233-2023-08522
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 10801741015363
• UDI-Public: (01)10801741015363
• 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: 03/21/2024

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 Catalogue Number: 787426
• Device Lot Number: NGHN1191
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/07/2023
• Initial Date FDA Received: 11/27/2023
• Supplement Dates Manufacturer Received: 03/21/2024
• Supplement Dates FDA Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2023
• 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