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

Model Number	776400
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	Pain (1994); Patient Problem/Medical Problem (2688); No Code Available (3191)
Date of Event	11/22/2019
Type of Reportable Event	Serious Injury
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 inlay stent became knotted at the end of the pigtail during use in the patient.The patient had to be anaesthetized for the stent to be removed, and experienced some pain after removal.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.Correction: d4 h11:section a through f - the information provided by bd represents all of 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 or Problem Description
It was reported that the inlay stent became knotted at the end of the pigtail during use in the patient.The patient had to be anaesthetized for the stent to be removed, and experienced some pain after removal.Per additional information from the ibc via email (b)(6)2020 ; the stent was removed during the original removal surgery, and was replaced with another stent.No further medical intervention was required.
Event or Problem Description
It was reported that the inlay stent became knotted at the end of the pigtail during use in the patient.The patient had to be anaesthetized for the stent to be removed, and experienced some pain after removal.Per additional information from the ibc via email 10jan2020; the stent was removed during the original removal surgery, and was replaced with another stent.No further medical intervention was required.
Additional Manufacturer Narrative
The reported event was confirmed as cause unknown.The device failed to meet specifications.The device was being used for treatment.The evaluation of the received photo samples showed a knot at the tip of the pigtail.However, the evidence was not sufficient to determine a definitive root cause.A potential root cause of the reported event could be improper material selection due to which the stent knotted at the end of the pigtail, resulting in patient discomfort, surgical intervention and replacement of device.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: ¿warning: inspect all guidewires for damage prior to use.Bending or kinking during or prior to placement could damage the guidewire.Do not attempt to use the guidewire if it has been damaged.Use of a damaged wire may result in damage to the urinary tract.Do not reshape the guidewire by any means.Attempting to reshape the guidewire may cause damage resulting in release of fragments into the urinary tract.Failure to exercise proper caution may result in damage to the urinary tract.Do not manipulate or remove the guidewire through a metal cannula or needle.This may result in destruction/ separation of the outer jacket of the wire requiring retrieval.Use extreme caution when using a laser, making sure to avoid contact with the wire.Direct contact could result in damage / breakage to the wire.Attention should be paid to guidewire movement in the urinary tract.Before a guidewire is moved or torqued, tip movement should be examined under direct vision or fluoroscopy.Do not advance or withdraw a guidewire when resistance is encountered as perforation could occur.Sufficient guidewire length must remain exposed to maintain a firm grip on guidewire at all times.Failure to comply with the warnings could result in damage to the guidewire to include, but not limited to: wire breakage, abrasion of the coating, release of guidewire fragments into the urinary system, all of which might require intervention.".

• Brand Name: BARD® INLAY® VERSA FIT® URETERAL STENT WITH HYDROGLIDE¿ GUIDEWIRE
• Common Device Name: INLAY MULTILENGTH URETERAL STENT W GUIDEWIRE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9572127
• Report Number: 1018233-2020-00219
• Device Sequence Number: 3043093
• Product Code: FAD
• UDI-Device Identifier: 10801741014151
• UDI-Public: (01)10801741014151
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K983498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/28/2023
• Device Model Number: 776400
• Device Catalogue Number: 777400
• Device Lot Number: NGCX3313
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2020
• Initial Date Received by Manufacturer: 12/16/2019
• Supplement Date Received by Manufacturer: 02/04/2020; 02/25/2020
• Initial Report FDA Received Date: 01/09/2020
• Supplement Report FDA Received Date: 02/10/2020; 03/02/2020
• 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: Required Intervention