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

Model Number 277405

Device Problem Inaccurate Flow Rate (1249)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/08/2022

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 user experienced hematuria and incomplete emptying while using ureteral stent.

Manufacturer Narrative

The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be "material selection".The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: ¿caution: federal (usa) law restricts this device to sale by or on the order of a physician.Information for use device description: the bard® fluoro-4¿ silicone ureteral stent, the bard® fluoro-4¿ silicone ureteral coil stent and the bard® silicone ureteral coil stent with figure four end are silicone stents.The bard® fluoro-4¿ silicone ureteral stent and the bard® fluoro-4¿ silicone ureteral coil stent are highly radiopaque.The extra coils enable the stent device to accommodate most lengths of ureters.Each stent kit contains the following: 1 bard® stent 1 guidewire 1 push catheter 1 stent clamp 1 information for use.Indications for use: these stents are indicated to relieve obstruction in a variety of benign, malignant and post-traumatic conditions in the ureter such as stones and/or stone fragments, or other ureteral obstructions such as those associated with ureteral stricture, carcinoma of abdominal organs, retroperitoneal fibrosis or ureteral trauma, or in association with extracorporeal shock wave lithotripsy (eswl).The stent may be placed using endoscopic surgical techniques or percutaneously using standard radiographic technique.Warning: this is a single use device.Do not resterilize any portion of this device.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient.Contraindications: there are no known contraindications to use.Precautions: 1.For single use only.Do not resterilize.Do not use if package or product is damaged.2.Improper handling technique can seriously weaken the stent.Acute bending or overstressing during placement could result in subsequent separation of the stent at the point of stress after a prolonged indwelling period.3.Exercise care.Tearing of the stent can be caused by sharp instruments.4.Choice of stent size and duration of indwelling time are at the discretion of the physician.All stents may be subject to varying degrees of encrustation when placed in the urinary tract.Periodic checks of the stent by cystoscopic and/or radiographic means are recommended.When at any time during the indwelling duration, encrustation is of sufficient severity that there is potential for occlusion of the stent or the patient experiences pain or discomfort which the physician determines to be associated with the presence of the stent, the stent or if there is indication of infection in the area of the stent.The stent should be removed and if the patient;s condition permits replaced with a new stent.5.Care should be exercised when removing the stent so as not to cause tearing or fragmentation.6.With any ureteral stent, migration is a possible complication which could require medical intervention for removal.Selection of too short a stent may result in migration.7.Multi-length ureteral stents: formation of knots in multi-length ureteral stents may occur.This may result in injury to the uretr during removal and/or the need for additional surgical intervention.The presence of a knot should be considered if significant resistance is encountered during attempts at removal." correction: g.H11: section a through f - the information provided by bd represents all 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.H3 other text : the device was not returned.

Event Description

It was reported that the user experienced hematuria and incomplete emptying while using ureteral stent.

• Brand Name: BARD® FLUORO-4¿ SILICONE URETERAL COIL STENT
• Type of Device: 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13980030
• MDR Text Key: 288630964
• Report Number: 1018233-2022-01886
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 10801741011747
• UDI-Public: (01)10801741011747
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K823487
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Study,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/24/2022

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
• Device Operator: Health Professional
• Device Model Number: 277405
• Device Catalogue Number: 277405
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2022
• Initial Date FDA Received: 04/01/2022
• Supplement Dates Manufacturer Received: 06/24/2022
• Supplement Dates FDA Received: 07/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other