MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® FLUORO-4¿ SILICONE URETERAL STENT

Model Number 233626

Device Problems Break (1069); Activation, Positioning or Separation Problem (2906)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 06/24/2019

Event Type  malfunction  

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 Description

It was reported that the stent could not be placed smoothly, the end tip of the device was suspected to be broken.

Manufacturer Narrative

The reported event was unconfirmed, since the reported failure could not be reproduced.Visual evaluation of the sample noted fluoro-4 silicone urethral stent and push catheter in open and original packaging.It was noted that the stent and push catheter seemed intact with no obvious damage.The length of the stent was measured (16.006") and noted to be within specification (16.063"±0.125.The outer diameter of the midpoint (0.0820") and at the end of the stent (0.0830") was within specification (0.079"±0.004").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: ¿1.Prior to removing guidewire from hoop, inject sterile water through port to activate lubricious coating.2.Pass the guidewire flexible tip beyond the obstruction to the renal pelvis.Note: tortuosity in the obstructed ureter can often be resolved using the guidewire and open end ureteral catheter in combination.3.Pass the stent over the guidewire through the cystoscope, advancing it into the ureter with the push catheter under direct vision.Assistant holds the guidewire in position to prevent advancement of the wire into the renal parenchyma.4.Watch for the distal end of the stent at the ureterovesical junction.Stop advancement of the stent at that point.Assistant removes the guidewire as the operator holds the stent in position with the push catheter.The retention coil will form spontaneously.Carefully remove the push catheter from the cystoscope." correction: d4, d10, h3 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 Description

It was reported that the stent could not be placed smoothly, the end tip of the device was suspected to be broken.

• Brand Name: BARD® FLUORO-4¿ SILICONE URETERAL STENT
• Type of Device: STENT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8812999
• MDR Text Key: 152034211
• Report Number: 1018233-2019-04105
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 10801741011686
• UDI-Public: (01)10801741011686
• Combination Product (y/n): N
• PMA/PMN Number: K823487
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: 233626
• Device Catalogue Number: 233626
• Device Lot Number: NGAW0415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2019
• Date Manufacturer Received: 08/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1