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U.S. Department of Health and Human Services


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Model Number 045215
Device Problems Break (1069); Material Frayed (1262)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Received 1 stone basket in open package. The reported event was confirmed with an unknown cause. The visual inspection noted that none of the basket wires had broken at the ball/tip and none of the four wires were compromised. The unit was clean. The broken component of the device was the orange polymide sheath that covers the length of the wire. The break was clean and no pieces of the broken sheath appear to be missing. No defects or conditions of the wire were noted that would have contributed to the broken sheath. Further inspection noted that the drive wire and sheath were kinked at the strain relief. While the root cause could not be determined, the damage to the device appears to have occurred post manufacturing. It is possible that the failure was caused by excessive force used when removing the product from the packaging; that the user removed the unit from the tray by unsnapping the handle and withdrawing the sheath and basket from the tray without removing the lid allowing the sheath and basket to catch between the lid and tray and bending/kinking the sheath and drive wires and breaking the sheath. It is also possible that damage to the sheath occurred because the user attempted to forcibly retract a basket containing a large stone back into the sheath. 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: "description: the flat wire stone basket consists of three main assemblies: 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 platinum class¿ flatwire 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 re-sterilize 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. Cautions: 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 rotate an open basket in the ureter. Potential complications that may result from the use of a basket in an endoscopic urological procedure include but are not limited to: perforation, edema, evulsion, entrapment, basket inversion, inability to disengage from, hemorrhage irretrievable object. Directions for use: only physicians trained in stone manipulation should perform this procedure. A variety of techniques in the use of this instrument may be employed; however, the physician should use the technique with which he/she is most familiar. Inspect the device prior to use and during the procedure. Retract instrument tip into sheath. In the closed position, insert the instrument into the ureteroscope working channel and advance the ureteroscope into the ureter or renal pelvis. With the basket closed/retracted, advance the instrument to the object to be removed. Push forward on thumb control knob to advance basket between object and ureteral wall. Once the object has been captured, partially close the basket to secure the object for removal. Simultaneously withdraw the basket and the ureteroscope from the urinary system. Handle disassembly/reassembly: if handle removal is desired: unscrew the thumb screw located on the basket handle. Gently pull backward on the handle, releasing both the handle and sheath from the drivewire/basket combination. If any resistance is felt at this stage, stop and determine cause of resistance. Once the stone burden within the basket has been removed, the basket can be closed using an open tip ureteral catheter. The basket can be reassembled easily by inserting the drivewire into the sheath and advancing until it reaches the handle. Tighten the thumb screw to secure the drivewire in place. " (b)(4).
Event Description
It was reported that after 1- 2 passes, the basket frayed and broke.
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 after 1- 2 passes, the basket frayed and broke.
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Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
Manufacturer (Section G)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
Manufacturer Contact
amy gravley
8195 industrial blvd
covington, GA 30014
MDR Report Key6699923
MDR Text Key267516422
Report Number1018233-2017-03603
Device Sequence Number1
Product Code FFL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/01/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/10/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2021
Device Model Number045215
Device Catalogue Number045215
Device Lot NumberBMAXMM04
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/10/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/24/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/23/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial