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

Model Number	777624
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
Event or Problem Description
It was reported that the ureteral stent broke, and the coil separated from the straight site after opening the package.It was confirmed that the customer had been replaced with a ureteral stent.
Additional Manufacturer Narrative
The reported event is confirmed, cause unknown.The ureteral stent was returned in the opened original packaging.An evaluation was completed by b.Bedwell at futurematrix on 17jan2022.Visual inspection of the sample noted the device was broken into two separate pieces.The separation appears similar in appearance to what is seen when the stent is cut with a pair of scissors as no stretching or discoloration was noted on the material.The suture port hole showed a break from the port hole to the end of the stent.The break looked similar to when a suture is forcefully pulled away from the stent causing the stent to rip.No additional damage was noted.The tip inner diameter was measured with a pin gage and found to be 0.043", the tube inner diameter was measured with a pin gage at both ends where the separation occurred and found to be 0.050", the outer diameter of the stent was measured with a laser micrometer and found to be 0.079"; all dimensions were within specifications.A 0.038" guidewire passed through each piece of the sample without resistance.A potential root cause for this event could be, "inappropriate package design" as no patient involvement was reported the device was not used, however, it is intended for treatment purposes.As damage was noted on the stent there appears to be a relationship between the device and reported event.No manufacturing issues or non-conformances were noted in the dhr review that could have caused or contributed to the reported event.Based on the results of the investigation, no additional action is required at this time.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: "do not use if the package or product is damaged." "improper handling technique can seriously weaken the stent." "care should be exercised when removing the stent from inner polybag so as not to cause tearing or fragmentation." the actual/suspected device was inspected.
Event or Problem Description
It was reported that the ureteral stent broke, and the coil separated from the straight site after opening the package.It was confirmed that the customer had been replaced with a ureteral stent.

• Brand Name: BARD® INLAY® URETERAL STENT WITH HYDROGLIDE¿ GUIDEWIRE
• Common Device Name: BARD® INLAY® URETERAL STENT WITH HYDROGLIDE¿ 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 12681895
• Report Number: 1018233-2021-06558
• Device Sequence Number: 19127523
• Product Code: FAD
• UDI-Device Identifier: 10801741014540
• UDI-Public: (01)10801741014540
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K983498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/14/2025
• Device Model Number: 777624
• Device Catalogue Number: 777624
• Device Lot Number: NGFP3211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/30/2021
• Supplement Date Received by Manufacturer: 03/22/2022
• Initial Report FDA Received Date: 10/22/2021
• Supplement Report FDA Received Date: 04/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown