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

Model Number	777628
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2021
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.
Event or Problem Description
It was reported that the front tip of the ureteral stent was found to be broken.
Additional Manufacturer Narrative
The reported event is confirmed, cause unknown.The ureteral stent was returned without the original packaging.An evaluation was completed by futurematrix on 10may2022.The breakage occurred from the suture porthole to the end of the stent.This kind of separation is seen when the suture is forcefully in the opposite direction from the stent.The suture was not provided for evaluation.As a 100% inspection was completed and the portholes are checked under 15x magnification prior to being sent to the customer, the stent is not believed to have been sent to the customer broken.A potential root cause for this event could be, "inappropriate package design".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: "improper handling technique can seriously weaken the stent." "suture may be cut off prior to stent placement.Remove suture prior to placement for pediatric patients." "exercise care.Tearing of the stent can be caused by sharp instruments." "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 front tip of the ureteral stent was found to be broken.

• Brand Name: BARD® INLAY® URETERAL STENT WITH HYDROGLIDE¿ GUIDEWIRE
• Common Device Name: 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13121681
• Report Number: 1018233-2021-08599
• Device Sequence Number: 17264643
• Product Code: FAD
• UDI-Device Identifier: 10801741014564
• UDI-Public: (01)10801741014564
• 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): 05/20/2022

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: 07/30/2024
• Device Model Number: 777628
• Device Catalogue Number: 777628
• Device Lot Number: NGFU0499
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/20/2021
• Supplement Date Received by Manufacturer: 05/20/2022
• Initial Report FDA Received Date: 12/30/2021
• Supplement Report FDA Received Date: 05/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2021
• 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