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

Model Number N/A

Device Problems Difficult to Remove (1528); Difficult to Open or Close (2921); Mechanical Jam (2983)

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

Event Date 04/26/2018

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.The device was not returned.

Event Description

It was reported that the basket did not close completely.The urologist was performing a flexible ureteroscopy.During capture of the calculus, the dimension basket did not close completely which prevented it from being safely removed from the patient.There was a delay in the procedure and additional surgical time to remove the basket.The doctor was able to fragment it and remove it safely from the patient.

Event Description

It was reported that the basket did not close completely.The urologist was performing a flexible ureteroscopy.During capture of the calculus, the dimension basket did not close completely, which prevented it from being safely removed from the patient.There was a delay in the procedure and additional surgical time to remove the basket.The doctor was able to fragment it and remove it safely from the patient.

Manufacturer Narrative

The reported event was unconfirmed.Evaluation of the sample returned noted the basket was fully articulated and out of the sheath.The handle of the shaft was severely bent.The basket was unarticulated and was able to be closed and opened normally.No manufacturing related defects could be detected.The basket functioned correctly.Although the root cause is unknown, it is determined that the potential root cause of the reported event is most likely use related.The basket was designed to not close if it was in an articulated position.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use states the following: ¿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.¿ 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 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 electrical equipment.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.Do not resterilize caution: federal (usa) law restricts this device to sale by or on the order of a physician.Packaging complies with the ordinance on the avoidance of packaging waste.Sterilized by ethylene oxide manufacturer u.S.Patent no.(b)(4).Do not use if product is damaged.Lot number.Units.Bard and bard dimension are trademarks and /or registered trademark of c.R.Bard, inc.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.".

• 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: 7539288
• MDR Text Key: 109238995
• Report Number: 1018233-2018-01838
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00801741066801
• UDI-Public: (01)00801741066801
• 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,other
• Type of Report: Initial,Followup
• Report Date: 08/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/23/2020
• Device Model Number: N/A
• Device Catalogue Number: 042310
• Device Lot Number: BMZBM032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2018
• Date Manufacturer Received: 08/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1