MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 EXPAND 212® HELICAL STONE BASKET WITH FILIFORM TIP

Model Number 041490

Device Problem Nonstandard Device (1420)

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

Event Date 06/02/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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 a physician stated in an online survey that they were not able to successfully remove the ureteral stone while using an expand stone basket because the stone was very large and residual concretions remained in situ.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be "basket geometry".It was unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.The dhr review could not be performed without a lot number.The instructions for use were found adequate and state the following: ¿expand 212¿ helical stone basket.For use with a ureteroscope having > 3.2 fr.Description: the expand 212¿ helical stone basket is torque stable and consists of three main parts: handle, shaft and basket.Indications for use: this device is intended for use in the endoscopic removal of renal and ureteral stones and calculi.Warnings: some objects may be too large to be removed endoscopically using a retrieval device.The use of fluoroscopy and/or x-ray to determine the size of the object is recommended; do not use the expand 212¿ helical stone basket if the object is too large to be removed endoscopically.This is a single use device.Do not resterilize any portion of this device.Reuse and/or repacking may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of device, which may lead to device failure, and/or lead to injury, illness or death of the patient.Caution: objects that are too large to be recovered through the sheath or through the scope channel will require the scope and basket to be removed simultaneously from the urinary tract.If resistance is encountered during advancement or withdrawal of the device, stop and determine the source of resistance, as continued resistance may damage the device and could result in patient injury.Take action to alleviate the resistance.Where necessary, use of a lithotrite may be required to reduce the stone burden within the basket, provided that no direct contact is made with the stone basket.Precautions: do not allow the device to come in contact with any electrified instrument.Do not allow the device to be directly fired upon by any lithotripsy device.To do so may damage the device and could result in patient injury.Potential complications that may result from the use of a basket in an endoscopic urological procedure include, but are not limited to: perforation, evulsion, edema, entrapment, basket inversion, hemorrhage, inability to disengage from irretrievable object.Directions for use: only physicians trained in stone manipulation should perform this procedure.A variety of techniques may be employed; however, the physician should use the technique with which he/she is most familiar.1.Inspect the device prior to use and during the procedure.2.Make sure the basket is closed by retracting the basket tip into sheath.3.Insert the basket into the ureteroscope working channel and advance the ureteroscope to the object to be removed.4.Under direct vision or fluoroscopic guidance, slowly advance the basket tip past the object.5.Open the basket.Pull the basket backward toward the object.While pulling the open basket past the object, slowly rotate in a counterclockwise direction.Once the object has been captured, partially close the basket to secure the object for removal.You may initially feel increased resistance as you retract the basket into the sheath.This is normal and an expected result of the initial compression of the stone basket elements.6.Simultaneously withdraw the basket and the ureteroscope from the urinary system.Directions to remove the handle: 1.Loosen the thumb screw (a).2.Press luer clip (b) and push away from handle.Warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and with applicable local, state and federal laws and regulations.¿ 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.

Event Description

It was reported that a physician stated in an online survey that they were not able to successfully remove the ureteral stone while using an expand stone basket because the stone was very large and residual concretions remained in situ.

• Brand Name: EXPAND 212® HELICAL STONE BASKET WITH FILIFORM TIP
• Type of Device: HELICAL STONE BASKET
• 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 17192109
• MDR Text Key: 317845124
• Report Number: 1018233-2023-04646
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00801741076480
• UDI-Public: (01)00801741076480
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 041490
• Device Catalogue Number: 041490
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2023
• 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