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	03/02/2021
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 crack was found on double j wall stent.Change a new one.
Event or Problem Description
It was reported that a crack was found on the double j wall stent.Changed a new one.
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 22jul2021.Separation of the stent was noted, however, the separation did not occur at a port hole.The sample did not appear to be stretched or have any material discoloration.The outer diameter was measured and found to be 0.080", which is within specifications of 0.079" +/- 0.002".The inner diameter was measured using a pin gage and was found to be 0.043", which is within specifications of 0.043" +/- 0.002".As no patient involvement was reported, the device was not used for treatment purposes though it was designed to be used for treatment.As damage was noted on the stent, there is a relationship between the reported event and the device.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.Acute bending or over stressing during placement could result in subsequent separation of the stent at the point of stress after a prolonged indwelling period." "care should be exercised when removing the stent from inner poly bag so as not to cause tearing or fragmentation." the actual/suspected device was inspected.

• 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: 11565989
• Report Number: 1018233-2021-01574
• Device Sequence Number: 14673005
• 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): 11/03/2021

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: 05/14/2025
• Device Model Number: 777624
• Device Catalogue Number: 777624
• Device Lot Number: NGEV4394
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/02/2021
• Supplement Date Received by Manufacturer: 11/03/2021
• Initial Report FDA Received Date: 03/24/2021
• Supplement Report FDA Received Date: 11/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2020
• 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