MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® DIMENSION® STONE BASKET

Model Number 042313

Device Problems Bent (1059); Break (1069)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 06/01/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bard 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 bard.

Event Description

It was reported that upon opening the stone basket during pre-test, one of the wires bent and broke.The staff retrieved a replacement stone basket.

Manufacturer Narrative

The reported event was unconfirmed as the sample returned did not show the reported event of a wire being broken.There was no damages were identified during the visual inspection or after unarticulating the basket.The basket was also tested to assess proper function, and the basket performed as normal the device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: "bard dimension stone basket information for use description: the bard dimension® stone basket is a teardrop-shaped basket with the ability to capture stones by: 1) simply opening and closing the basket and 2) articulating or moving the basket side to side.The device consists of 3 main parts: handle, shaft and basket.Indications for use: this device is intended for use in the endoscopic removal of renal and ureteral stones.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 bard dimension® stone basket if the object is too large to be removed endoscopically.¿ after use this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practices and applicable laws and regulations.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 most appropriate for the individual patient¿s situation.1.Inspect the device prior to use and during the procedure.2.Make sure the basket is closed by retracting the basket-tip into the sheath with the thumb slide (a).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 tip of the stone basket past the object.Conventional use: ¿ open the basket with the thumb slide (a).Pull the basket backward toward the object while slowly rotating the basket.Once the object has been captured, partially close the basket to secure the object for removal by pulling the thumb slide (a) back.¿ simultaneously, withdraw the basket and the ureteroscope from the urinary system.Articulating use: ¿ use the control wheel (b) to articulate the basket by moving the wheel forward or backward.Articulate the basket as needed to capture the object.Once the object has been captured, partially close the basket to secure the object for removal by pulling the thumb slide (a) back.¿ simultaneously, withdraw the basket and the ureteroscope from the urinary system." correction: mfr site.

Event Description

It was reported that upon opening the stone basket during pre-test, one of the wires bent and broke.The staff retrieved a replacement stone basket.

• Brand Name: BARD® DIMENSION® STONE BASKET
• Type of Device: STONE BASKET
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7647974
• MDR Text Key: 112844949
• Report Number: 1018233-2018-02482
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00801741066818
• UDI-Public: (01)00801741066818
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/14/2018

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 Expiration Date: 07/01/2022
• Device Model Number: 042313
• Device Catalogue Number: 042313
• Device Lot Number: BMBUMM09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2018
• Initial Date Manufacturer Received: 06/04/2018
• Initial Date FDA Received: 06/28/2018
• Supplement Dates Manufacturer Received: 08/23/2018
• Supplement Dates FDA Received: 09/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1