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

Model Number	777624
Medical Device Problem Codes	Accessory Incompatible (1004); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2021
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 inner tube polyamide was out together along with the guidewire while removing the guidewire.Stated that another new tumor stent was used.
Additional Manufacturer Narrative
Per additional information received, it has been determined that this mdr event is not reportable.The device was not returned.
Event or Problem Description
It was reported that the inner tube polyamide was out together along with the guidewire while removing the guidewire.Stated that another new tumor stent was used.

• 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
• MDR Report Key: 11945879
• Report Number: 1018233-2021-03261
• Device Sequence Number: 16432318
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2021

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: 07/07/2025
• Device Model Number: 777624
• Device Catalogue Number: 777624
• Device Lot Number: NGEW3321
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/13/2021
• Supplement Date Received by Manufacturer: 07/28/2021
• Initial Report FDA Received Date: 06/07/2021
• Supplement Report FDA Received Date: 08/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other