MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 EXPAND212® HELICAL STONE BASKET

Model Number 040490

Device Problems Break (1069); Detachment Of Device Component (1104)

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

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 the handle of the stone basket broke off while using.No medical intervention reported.

Manufacturer Narrative

The reported event is confirmed; however, the root cause is unknown.Evaluation of the returned sample by the supplier (b)(4) noted that the sample was received severely damaged in four separate pieces.The basket was deformed which suggests excessive force was applied to the device the thumbscrew was loosened and the support tube detached.Witness marks typical of a properly torqued device were present on the dog-point of the thumbscrew (proper clockwise increasing deformation).The screw threads were clean and free of obstructions.The thumbscrew freely screws into thumb slide to the proper depth.The sheath was cut in half (clan scissors cut, not a tensile break) and crushed in many places.The cut and crushing occurred after the basket assembly was removed from the sheath and therefore done external to the patient and endoscope.The support tube was deformed in a way that could not be replicated in an assembly condition.No manufacturing defects could be found among the many abused areas of the returned device.The most likely root cause of the reported event is rough handling in the field.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: "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.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 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 practices and applicable laws and regulations." h11: section a through f - 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 the handle of the stone basket broke off while using.No medical intervention reported.

• Brand Name: EXPAND212® HELICAL STONE BASKET
• Type of Device: HELICAL STONE BASKET
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7244137
• MDR Text Key: 99359077
• Report Number: 1018233-2018-00356
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 00801741076466
• UDI-Public: (01)00801741076466
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2018
• 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: 040490
• Device Catalogue Number: 040490
• Device Lot Number: GFBV4347
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2018
• Date Manufacturer Received: 04/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1